NCT05842057View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

August 24, 2023

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2028

Conditions
Prostate CancerErectile Dysfunction Following Radical Prostatectomy
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.

Trial Locations (1)

33136

University of Miami, Miami

Sponsors
All Listed Sponsors
collaborator

Integra LifeSciences Corporation

INDUSTRY

lead

University of Miami

OTHER

NCT05842057 - Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy | Biotech Hunter | Biotech Hunter