Tubularized augmented peritoneal cap vaginoplasty using a treated cod-skin graft (Kerecis)
Official title: Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)
Run by University Hospitals Cleveland Medical Center · NCT07286123 · Data updated 2026-11-12
This project tests using a treated cod-skin graft (Kerecis) to line part of the vagina during robotic gender-affirming vaginoplasty for transgender women.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years to 99 Years |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | July 22, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT07286123 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Transgender women aged 19–99 planning primary robotic TAPCap vaginoplasty at University Hospitals Cleveland who are not seeking revision surgery and who have no fish or local anesthetic allergy.
✕Probably not a fit
Patients needing revision vaginoplasty, zero-depth procedures, those requiring grafts other than Kerecis, or anyone allergic to fish products or the local anesthetic are unlikely to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational protocol follows transgender women aged 19–99 who undergo robotic tubularized augmented peritoneal cap (TAPCap) vaginoplasty in which Kerecis fish-skin xenograft is used to line the mid-vaginal canal as part of routine surgical care. Surgeons will perform the TAPCap technique with Kerecis during planned primary vaginoplasty and collect perioperative data and biopsy samples. The study excludes revision cases, zero-depth vaginoplasty, patients requiring other off-the-shelf grafts, and those with allergies to fish products or local anesthetic. Outcomes will emphasize surgical feasibility, wound healing and lining integrity, and short-term complications at a single center in Cleveland, Ohio.
Why it matters
Potential benefit: If successful, this approach could provide a durable, skin-sparing vaginal lining that reduces donor-site morbidity and improves healing and cosmetic outcomes.
How similar studies have gone: Fish-skin grafts such as Kerecis have shown positive results in wound healing and some soft-tissue reconstruction settings, but use specifically for lining in vaginoplasty is novel and has limited published outcome data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 19-99 * Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique Exclusion Criteria: * Patients requiring Kerecis for Revision Vaginoplasty * Surgery candidates having Zero depth vaginoplaty (ZDV) * Non-Gender Affirming Vaginoplasty * Cases requiring the utilization of off-the-shelf grafts other than Kerecis * Allergy to fish products * Allergy to local anesthetic (1% lidocaine with epinephrine injection)
Where it's running
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Shubham Gupta, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Seyed Sajjad Tabei, MD
- Email: seyedsajjad.tabei@uhhospitals.org
- Phone: 216-844-8963
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.