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 NA
Principal Investigator Yael Vin, MD MPH
Division Transplantation
Project Coordinator Claire Rosenwasser
Status Submitted for IRB Review
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
Project Coordinator Claire Rosenwasser
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 — Pending IRB approval
ClinicalTrials.gov NA
Principal Investigator Dhruv Singhal, MD
Division Plastic and Reconstructive Surgery
Project Coordinator Leo Magrini
Status Not Yet 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 — Pending IRB approval
ClinicalTrials.gov Pending
Principal Investigator Dhruv Singhal, MD
Division Plastic and Reconstructive Surgery
Project Coordinator Leo Magrini
Status Not Yet 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 House Calls and Peer Mentorship: Increasing Access to Live Donor Transplantation
IRB No. Pending IRB approval
ClinicalTrials.gov Pending
Principal Investigator James Rodrigue, PhD
Division Transplantation
Project Coordinator Mario Feranil
Status Submitted for IRB Review
Description The objective of this PCORI funded study is to evaluate the differential benefit of adding a patient-centered peer mentorship component to the House Calls intervention.


Title Increasing VCA Donation Knowledge, Attitudes, Willingness, and Designations in Veterans
IRB No. Pending IRB approval
ClinicalTrials.gov Pending
Principal Investigator James Rodrigue, PhD
Division Transplantation
Project Coordinator Stephanie Ward
Status Preparing IRB application
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, RCT) 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 Living Donor Wage Reimbursement Trials
IRB No. 2017P000213 — Pending IRB approval
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03268850
Principal Investigator James Rodrigue, PhD
Division Transplantation
Project Coordinator Michaela Carroll
Status Submitted for IRB Review
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
Project Coordinator Michaela Carroll
Status Not Yet 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 Lymphedema Surgery Biorepository
IRB No. 2017P000190
ClinicalTrials.gov N/A
Principal Investigator Dhruv Singhal, MD
Division Plastic Surgery
Project Coordinator Leo Magrini
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 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 R. Rodrigue, PhD
Division Transplantation
Project Coordinator Sarah Duncan
Status Not Yet 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 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
Project Coordinator Stephanie Ward
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
Project Coordinator Stephanie Ward
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
Project Coordinator Stephanie Ward
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
Project Coordinator Aaron Fleishman
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
Project Coordinator Mario Feranil
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
Project Coordinator Stephanie Ward
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
Project Coordinator Mario Feranil
Status Recruiting
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
Project Coordinator Stephanie Ward
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
Project Coordinator Aaron Fleishman
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 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
Project Coordinator Stephanie Ward
Status Active; Data Collection
Description


Quality Improvement Divisional Databases

Title BIDMC Breast Cancer Surgery Database
Division Breast Surgical Oncology
Project Coordinator Leo Magrini
Description Quality Improvement Database for Breast Cancer surgery patients


Title BIDMC Lymphedema Database
Division Plastic Surgery
Project Coordinator Leo Magrini
Description Quality Improvement Database for Lymphedema patients