Actively Recruiting
Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Using Fish Skin Graft (Kerecis™)
Led by University Hospitals Cleveland Medical Center · Updated on 2025-12-16
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospitals Cleveland Medical Center
Lead Sponsor
K
Kerecis Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on transgender women undergoing bottom gender affirming surgery, specifically robotic vaginoplasty using a Tubularized Augmented Peritoneal Cap (TAPCap) technique. The study aims to assess healing changes after using a special graft called Kerecis™, made from treated North Atlantic cod skin, which lines the middle part of the newly constructed vagina. The trial seeks to evaluate how this graft affects healing and quality of life in up to 20 participants. The surgery involves creating the distal part of the neovagina from inverted penile skin, the proximal part from peritoneal tissue, and lining the area in between with the Kerecis graft. Biopsies will be taken six months after surgery from different parts of the neovagina to examine healing under a microscope. Participants will be followed up with questionnaires at 2 weeks, 12 weeks, 6 months, and 1 year post-operation to measure healing, vaginal dimensions, pain, quality of life, and sexual function. Participants will complete several assessments including the Short-Form 36 for quality of life, Brief Pain Inventory, Female Genitourinary Pain Index, Patient Global Impression of Improvement, and Female Sexual Function Index. The study will monitor changes in vaginal epithelialization, diameter, and depth at various postoperative points. The total participation lasts up to one year with detailed follow-up visits and biopsies to observe healing progress and patient-reported outcomes.
CONDITIONS
Brief Title
Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 to 99 years
- Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique
You will not qualify if you...
- Patients requiring Kerecis for Revision Vaginoplasty
- Candidates for Zero depth vaginoplasty (ZDV)
- Non-Gender Affirming Vaginoplasty cases
- Cases using grafts other than Kerecis
- Allergy to fish products
- Allergy to local anesthetic (1% lidocaine with epinephrine injection)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo gender affirming robotic vaginoplasty with the TAPCap technique using a fish skin graft (Kerecis™).
1 surgery visit and immediate post-operative care
Duration - Up to 1 year post-surgery
Participants have follow-up visits to monitor changes in vaginal diameter, depth, quality of life, pain, and perception of improvement.
Visits at Week 2, Week 12, Month 6, and Year 1 post-op
Duration - At 6 months post-op
Biopsies are obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina to assess epithelialization.
1 biopsy visit (in-person)
Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
S
Seyed Sajjad Tabei, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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