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Liquid Buccal Mucosa Graft Urethroplasty

NCT03061344 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-02-23

No results posted yet for this study

Summary

Study Objectives The current definitive treatment options for urethral stricture disease include endoscopic urethrotomy known as Direct Vision Internal Urethrotomy (DVIU) or open reconstruction known as urethroplasty (1-6). The purpose of this study is to determine feasibility of endoscopic-only repair of urethral stricture or bladder neck contracture using a combination of existing surgical techniques of internal urethrotomy (or bladder neck incision) augmented by buccal mucosal graft.

Conditions

  • Urethral Stricture

Interventions

BIOLOGICAL

DVIU treated with liquid buccal mucosal graft

DVIU treated with liquid buccal mucosal graft; internal urethrotomy for urethral stricture followed by injection of morcellated buccal mucosal graft mixed with fibrin glue (Tisseel, Baxter)

Sponsors & Collaborators

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Dmitriy Nikolavsky, MD · State University of New York - Upstate Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2019-10-31
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061344 on ClinicalTrials.gov