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NCT02395497 · ClinicalTrials.gov registry record · Phase 2
Human Penile Allotransplantation
A Phase 2 study of Amputation and Wounds and Injuries, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT02395497 is a Phase 2 study of Amputation and Wounds and Injuries that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 60 participants, below the 132-participant average among 65 other Amputation trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02395497, a Phase 2 study of Amputation and Wounds and Injuries, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction. The investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace "like with like," restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results. Study Design: This is a non-randomized subject self-controlled cli
Conditions Studied
Interventions
- DRUG Tacrolimus
- BIOLOGICAL Monoclonal Antibody (Humanized Anti-CD52)
- PROCEDURE Penile Allotransplantation
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-06 |
| Est. Completion | 2039-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02395497
The ClinicalTrials.gov registry entry for NCT02395497 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 132-participant average among 65 other Amputation trials with a reported enrollment target (55% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Amputation appearing as the primary indexed condition, and to 3 interventions - of which Tacrolimus is the first listed.
NCT02395497 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02395497 about?
NCT02395497 is a clinical study titled "Human Penile Allotransplantation". Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions c...
What is the current status of trial NCT02395497?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2014-06. Estimated completion is 2039-06.
What conditions does trial NCT02395497 study?
This clinical trial studies the following conditions: Amputation, Wounds and Injuries, Amputation, Traumatic, Amputation, Traumatic/Surgery, Urologic Surgical Procedures, Male.
What interventions are being tested in trial NCT02395497?
The interventions under investigation include: Tacrolimus (DRUG), Monoclonal Antibody (Humanized Anti-CD52) (BIOLOGICAL), Penile Allotransplantation (PROCEDURE).
Who is sponsoring clinical trial NCT02395497?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02395497 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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