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Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy

NCT05842057 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-07-22

No results posted yet for this study

Summary

The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.

Conditions

Interventions

BIOLOGICAL

BioDFence G3 Placental Tissue Membrane

The BioDFence G3 Placental Tissue Membrane is a three-layer tissue allograft consisting of amnion-chorion-amnion. Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP. The membrane will be cut into two longitudinal pieces and placed over each neurovascular bundle separately.

PROCEDURE

Robot-Assisted Radical Prostatectomy

Robot-assisted surgical removal of the prostate, administered standard of care.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Sanoj Punnen, MD, MAS · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-24
Primary Completion
2027-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05842057 on ClinicalTrials.gov