FIRST-Assisted Studies

Active Projects Supported by FIRST Program

Research Protocols

Title A multi-center prospective study to evaluate the safety and effectiveness of the VasQ external support for arteriovenous fistula
IRB No. 2017P000576
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03242343
Principal Investigator Yael Vin, MD MPH
Division Transplantation
Status Recruiting
Description This is a prospective, multi-center, single arm, open label, clinical study of the Laminate VasQ external support for arteriovenous fistulas. The VasQ is intended for use as an external support for vascular access and is designed to improve fistula patency and maturation.


Title Role of Matrix Metalloproteinases (MMPs) in Arterial Calcification
IRB No. 2017P000496
ClinicalTrials.gov NA
Principal Investigator Raul Guzman, MD
Division Vascular and Endovascular Surgery
Status Data Analysis
Description This study aims to examine de-identified CT images obtained from subjects who participate in an ongoing clinical trial (N-TA3CT trial) examining the use of doxycycline to limit aortic aneurysm expansion.


Title Acupuncture for Breast Cancer Related Lymphedema: A Pilot Study
IRB No. 2017P000433
ClinicalTrials.gov NA
Principal Investigator Dhruv Singhal, MD
Division Plastic and Reconstructive Surgery
Status Recruiting
Description The goal of this research is to demonstrate the feasibility and preliminary efficacy of acupuncture for breast cancer related lymphedema while beginning to explore the mechanistic underpinnings of this treatment.


Title Measuring Skin Elasticity in Lymphedema Patients
IRB No. 2017P000378
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03313999
Principal Investigator Dhruv Singhal, MD
Division Plastic and Reconstructive Surgery
Status Recruiting
Description This study will utilize the durometer (a novel, noninvasive piece of equipment that measures skin elasticity) to better characterize disease progression in patients with lymphedema. BIDMC patients who undergo treatment of lymphedema will be candidates for this noninvasive test. This device and the data it generates will help understand the incidence of lymphedema at BIDMC compared to national data and the outcomes of surgical treatment of lymphedema.


Title Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation
IRB No. 2017P000521
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03354910
Principal Investigator James R. Rodrigue, PhD
Division Transplantation
Status Recruiting
Description This study will examine the impact of a peer mentorship program of the National Kidney Foundation in conjunction with the House Call (HC)intervention on rates of live donor kidney transplantation. House Calls, an educational intervention developed by this study’s PI, has been shown to be an effective program for raising rates of live donation, especially for black patients. Previous research suggests that peer mentorship from former or current patients with ESRD may be effective in raising rates of living donation. As such, peer mentorship programs may act as an effective follow-up for HC participants.


Title Self-directed post procedural diet advancement: Feasibility study
IRB No. 2018P000169
ClinicalTrials.gov NA
Principal Investigator Vitaliy Poylin, MD
Division Colon and Rectal
Status Recruiting
Description The Patient Autonomous Diet Advancement Tool assesses how patients feel about their diet and eating following a colectomy. We hope to evaluate the feasibility of using this tool for patient nutrition post colectomy. We are interested in patient perceptions of this tool that we can use it to modify it for use in future studies.


Title Increasing VCA Donation Knowledge, Attitudes, Willingness, and Designations in Veterans
IRB No. 2017P000656
ClinicalTrials.gov NA
Principal Investigator James Rodrigue, PhD
Division Transplantation
Status Recruiting
Description The objective of this HRSA funded study is to use a mixed-methods approach to develop (survey, focus groups) and evaluate (randomized controlled trial) targeted video interventions designed to increase VCA donation knowledge, attitudes, intentions, designations in a diverse veterans population, as well as enhance their commitment to authorize VCA donation for a deceased relative or significant other.


Title Outcomes Following Open or Minimally Invasive Colectomy with Rapid Recovery Pathway
IRB No. 2010P000263
ClinicalTrials.gov NA
Principal Investigator Vitaliy Poylin, MD
Division Colon and Rectal Surgery
Status Active; Data Collection
Description To assess outcomes of open and minimally-invasive colon resections for treatment of benign and malignant disease and the effects of rapid recovery pathways on post-operative course.


Title Outcomes in inflammatory bowel disease
IRB No. 2018P000258
ClinicalTrials.gov NA
Principal Investigator Vitaliy Poylin, MD
Division Colon and Rectal Surgery
Status Active; Data Collection
Description The purpose of this protocol is to create a database examining patients at Beth Israel Deaconess Medical Center who have a diagnosis of inflammatory bowel disease (IBD). We plan to use the repository to assess outcomes of current management of IBD.


Title Is there an optimal level of hallux amputation in patients with diabetes and osteomyelitis?
IRB No. 2017P000305
ClinicalTrials.gov NA
Principal Investigator John M. Giurini, DPM
Division Podiatry
Status Active; Data Collection
Description Amputations of the great toe are commonly performed procedures in diabetic patients with foot ulcerations and bone infection. The literature does not show an optimal location for these amputations. Are certain locations more prone to complications than other locations, resulting in return to the operating room?


Title Reconstructive Surgery in Diabetic Patients with Charcot Joint Disease: A Retrospective Review with 10-Year Follow-up
IRB No. 2017P000368
ClinicalTrials.gov NA
Principal Investigator John M. Giurini, DPM
Division Podiatry
Status Active; Data Collection
Description Charcot joint disease is a complication of diabetes that can result in significant deformity and instability of the foot. This can often result in major limb amputations. The current study reviews the efficacy and outcomes of long-term reconstructive limb preservation surgery in this patient population.


Title Living Donor Wage Reimbursement Trial
IRB No. 2017P000213
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03268850
Principal Investigator James Rodrigue, PhD
Division Transplantation
Status Recruiting
Description Many living kidney donors have substantial non-reimbursed direct and indirect costs, most notably the loss of income or wages following surgery. In this NIH funded study, we will: (1) evaluate the effectiveness of offering reimbursement for living donor (LD) lost wages on the living donor kidney transplant (LDKT) rate; (2) examine whether offering reimbursement for LD lost wages reduces known racial disparities in LDKT; and (3) determine whether study outcomes differ significantly by maximum reimbursement amount for LD lost wages.


Title Barrett’s Esophagus Pilot Study
IRB No. 2017P000203
ClinicalTrials.gov N/A
Principal Investigator Alia Qureshi, MD
Division General Surgery
Status Recruiting
Description This study aims to examine the phosphoproteomic profile of esophageal cells of patients with Barrett’s esophagus or Barrett’s with dysplasia. From this, it is hoped that a protein marker will be identified that indicates whether or not the patient will progress along the BE pathway.


Title Kidney Paired Donation: a Randomized Trial to Increase Knowledge and Informed Decision-Making
IRB No. 2016P000409
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03013829
Principal Investigator James Rodrigue, PhD
Division Transplantation
Status Recruiting
Description The purpose of this study is to evaluate the effectiveness of a targeted educational approach designed to increase knowledge about the risks and benefits of living donation generally and KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns, and facilitate informed decision making about KPD among incompatible or cross-match positive donor-recipient pairs.


Title BIDMC High Risk Breast Lesion Registry
IRB No. 2017P000248
ClinicalTrials.gov N/A
Principal Investigator Ted James, MD
Division Surgical Oncology
Status Recruiting
Description Treatment of high risk breast lesions is a highly debated field in breast surgery with a variety of treatment options available that frequently differ between practices. The primary goal of this registry is to identify clinical characteristics correlated with survival and quality of life outcomes in patients with high risk breast lesions. It is hoped that the information gained from this study will help to better inform decision making for patients with high risk breast lesions. This registry will collect data on patients with high risk lesions both undergoing surgery and being closely observed per standard of care protocols.


Title Circulating Proteins in Breast Cancer-Related Lymphedema
IRB No. 2018P000320
ClinicalTrials.gov N/A
Principal Investigator Dhruv Singhal, MD
Division Plastic and Reconstructive Surgery
Status Recruiting
Description This study plans to identify biomarkers that are specific to lymphedema in subjects with a history of breast cancer. Though there are some known risk factors for the development of lymphedema after breast cancer treatment, questions remain as there are many patients with the same risk factors that do not develop lymphedema. If there are differences found between those with and without lymphedema, further study would be done to better characterize these findings. Elevated proteins could serve as both biomarkers to better stratify patients’ risk prior to breast cancer surgery or after breast cancer surgery for early detection and possible intervention. These findings could also lend insight into the underlying mechanisms and pathophysiology of lymphedema and aid in the explanation of why some patients develop lymphedema with the same risk factors.


Title A Randomized, Placebo Surgery Controlled, Double-blinded, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Advanced Parkinson’s Disease with Motor Fluctuations
IRB No. Pending
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03562494
Principal Investigator Ron Alterman, MD
Division Neurosurgery
Status Pending IRB Submission
Description Voyager Therapeutics is sponsoring this therapeutic study to investigate how effective and safe their investigational product (VY-AADC02), a gene therapy encoding the human gene for the conversion of levodopa to dopamine in the brain, as an agent for treating Advanced Parkinson’s Disease with motor fluctuations. This will be done by a neurosurgical intervention where the study product is infused into the putamen. This study also involves a placebo surgery control group.


Title An Evaluation of Lymphatic Surgery Samples
IRB No. 2018P000191
ClinicalTrials.gov N/A
Principal Investigator Dhruv Singhal, MD
Division Plastic and Reconstructive Surgery
Status Active; Data Analysis
Description The purpose of this study is to conduct preliminary analyses on samples in the Lymphedema Surgery biorepository (IRB Protocol 2017P-000190) to assess if current sample handling procedures are adequate to maintain sample integrity for further analyses. Initial analyses will include investigation of tissue morphology (structure and design), genetic testing identification of mutations or genes and assessment of biomarkers that may be associated with lymphedema. This research may elucidate biological processes that predispose or increase risk of lymphedema development.


Title Lymphedema Surgery Biorepository
IRB No. 2017P000190
ClinicalTrials.gov N/A
Principal Investigator Dhruv Singhal, MD
Division Plastic Surgery
Status Recruiting
Description This is a biorepository for samples from patients undergoing lymphatic surgery at BIDMC. The tissue will be used for future research to study lymphatic structure and identify genes, biomarkers and biological processes that put patients at risk of developing lymphedema.


Title Recurrent Clostridium Difficile and CMV Infection in Patients with Ulcerative Colitis
IRB No. 2016P000311
ClinicalTrials.gov N/A
Principal Investigator Vitaliy Poylin, MD
Division Colon and Rectal Surgery
Status Active; Data Collection
Description The goal of this study is to investigate chances recurrent infection and outcomes of c diff and CMV in patients undergoing surgery for ulcerative colitis.


Title Extended Appendectomy for Appendiceal Orifice Polyps
IRB No. 2015P000164
ClinicalTrials.gov N/A
Principal Investigator Vitaliy Poylin, MD
Division Colon and Rectal Surgery
Status Active; Data Analysis
Description The goal of this study is to investigate the best approach for treatment of appendiceal polyps.


Title Repair of Rectal Prolapse in Men
IRB No. 2015P000132
ClinicalTrials.gov N/A
Principal Investigator Vitaliy Poylin, MD
Division Colon and Rectal Surgery
Status Active; Data Analysis
Description The goal of this multicenter retrospective study is to evaluate potential risk factors for rectal prolapse repair in men and the outcomes of various surgical approaches to treat it.


Title Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver’s Education Intervention
IRB No. 2015P000063
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03013816
Principal Investigator James R. Rodrigue, PhD
Division Transplantation
Status Active; Data collection
Description The objective of this study is to evaluate the effectiveness of targeted video interventions designed to increase organ donation knowledge, intentions, and designations among adolescents enrolled in driver’s education classes, as well as to increase the commitment of parents/legal guardians to authorize organ donation in the event of their adolescent’s death. The central hypothesis is that integrating donation education into the driver’s education curriculum will increase knowledge and attitudes that facilitate the behavioral action of donor designation at the time of getting a new driver’s license.


Title Readiness for Live Donor Kidney Transplantation
IRB No. 2014P000373
ClinicalTrials.gov N/A
Principal Investigator James R. Rodrigue, PhD
Division Transplantation
Status Recruiting
Description The aims of this study are to (a) characterize the living donor kidney transplant (LDKT) knowledge, concerns, and behaviors of patients on the kidney transplant waiting list, (2) evaluate the relationship between these measures, sociodemographic and medical characteristics, and living donor evaluations conducted, and (3) gather descriptive data on several new measures developed for use with this patient population.


Title Use of Flomax to Decrease Urinary Retention after Pelvic Surgery
IRB No. 2014P000172
ClinicalTrials.gov N/A
Principal Investigator Vitaliy Poylin, MD
Division Colon and Rectal Surgery
Status Active; Data Analysis
Description The purpose of this study is to understand the effects of the use of Flomax (tamsulosin) on rates of urinary retention after pelvic surgery in men.


Title House Calls and Decision Support: Improving Access to Live Donor Transplantation
IRB No. 2012P000332
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01786525
Principal Investigator James R. Rodrigue, PhD
Division Transplantation
Status Active; Data Collection and Analysis
Description The main purpose of this research program is to reduce the burden of end-stage organ disease on individuals, families, healthcare systems, and society by increasing the availability of donor organs for transplantation. Consistent with this aim, the project further examines strategies to increase access to and reduce disparities – racial, economic, gender – in live donor kidney transplantation (LDKT). Specifically, we expand the research and intensity of an innovative House Calls intervention developed by the principal investigator by including other minorities and socioeconomically disadvantaged patients and by adding a novel Patient-Centered Decision Support component. The main study hypothesis is that participants receiving the novel intervention (House Calls + Patient-Centered Decision Support) will have a higher proportion of LDKT’s by the 2-year study endpoint.


Title Ileostomy Pathway Virtually Eliminates Readmissions for Dehydration in New Ileostomates
IRB No. 2012P000156
ClinicalTrials.gov NA
Principal Investigator Vitaliy Poylin, MD
Division Colon and Rectal Surgery
Status Active; Data Analysis
Description The purpose of this research study is to assess outcomes after implementation of a pathway for education and management of patients with new ileostomies.


Title Kidney Donor Outcomes Cohort (KDOC) Study
IRB No. 2010P000286
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01427452
Principal Investigator James R. Rodrigue, PhD
Division Transplantation
Status Active; Data Analysis
Description The objective of this study is to establish a multisite prospective cohort of living kidney donors, their recipients, and a healthy comparison group. This cohort will be used to examine three primary aims: (1) to assess donor outcomes (surgical, medical, functional, psychological, financial) over a 2-year period initially, with the intention of examining these outcomes over a more extended time period in subsequent years; (2) to identify the donor, recipient, and center variables that are most predictive of donor outcomes; and (3) to identify disparities in donor outcomes and their predictors. To accomplish these aims, six kidney transplant programs, representing six states (Massachusetts, Maine, Rhode Island, New York, Iowa, and Arizona) and with experience and expertise in caring for living donors and transplant recipients, will participate in the study. Donors, their recipients, and healthy controls will complete comprehensive assessments at baseline (pre-surgery) and at 1, 6, 12, and 24 months post-donation. This study will extend the investigators considerable preliminary work by simultaneously examining outcomes that are of importance to donors, recipients, healthcare providers, and policymakers. The rationale for this research is that, once these outcomes and their predictors are known, investigators can further develop and refine educational strategies and informed consent processes for both living donors and their intended recipients, as well as provide systematic data to inform policy discussions and clinical care practice.


Title Endocrine Surgery Biorepository
IRB No. 2018P000312
ClinicalTrials.gov N/A
Principal Investigator Benjamin James, MD MS
Division Surgical Oncology
Status Recruiting
Description The purpose of this protocol is to establish a biorepository containing biological samples from patients who are undergoing thyroid, parathyroid and adrenal surgery at Beth Israel Deaconess Medical Center. The Endocrine Surgery Biorepository will be used for future research to study pathology, biomarkers, biological processes, and genetic markers associated with surgical endocrine disorders.


Title Long Term Voice Changes and Financial Burden in Thyroid Disease Patients
IRB No. 2018P000468
ClinicalTrials.gov N/A
Principal Investigator Benjamin James, MD MS
Division Surgical Oncology
Status Recruiting
Description The purpose of this study is to evaluate two of the long-term effects of the surgical treatment of thyroid disease: voice changes and financial burden.


Title Association of Burnout and Surgical Subspecialty Career Choice
IRB No. 2018P000379
ClinicalTrials.gov N/A
Principal Investigator Benjamin James, MD MS
Division Surgical Oncology
Status Recruiting
Description The purpose of this study is to assess whether resident burnout may be associated with the decision to pursue certain surgical specialties.


Title Creating a National Resource for Opioid Prescribing Across Surgical Specialties
IRB No. 2017P000304
ClinicalTrials.gov N/A
Principal Investigator Gabriel Brat, MD MPH
Division Acute Care & Trauma Surgery
Status Recruiting
Description This project will identify the quantity of opioids required for the typical post-operative patient after discharge for a subset of the most common ~50 surgical procedures. This data will be used to establish a resource to guide prescribers on typical opioids required for postoperative pain management.


Title A Text Messaging System to Provide Sustainable Post-Discharge Surgical Opioid Use Data
IRB No. Pending
ClinicalTrials.gov N/A
Principal Investigator Gabriel Brat, MD MPH
Division Acute Care & Trauma Surgery
Status Pending IRB Approval
Description The purpose of this project is to continue to identify the quantity of opioids required for the typical post-operative patient after discharge from the hospital. In order to increase patient participation and broaden applicability, this protocol will utilize a voluntary online survey sent via text message to BIDMC patients.


Quality Improvement Divisional Databases

Title BIDMC Breast Cancer Surgery Database
Division Breast Surgical Oncology
Description Quality Improvement Database for Breast Cancer surgery patients


Title BIDMC Lymphedema Database
Division Plastic Surgery
Description Quality Improvement Database for Lymphedema patients