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Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
Sponsor: University of Miami
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.
Official title: Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)
Key Details
Gender
MALE
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2023-08-24
Completion Date
2028-08-31
Last Updated
2025-07-22
Healthy Volunteers
No
Interventions
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.
Robot-Assisted Radical Prostatectomy
Robot-assisted surgical removal of the prostate, administered standard of care.
Locations (1)
University of Miami
Miami, Florida, United States