Trials / Active Not Recruiting
Active Not RecruitingNCT05842057
Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (actual)
- Sponsor
- University of Miami · Academic / Other
- Sex
- Male
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-08-24
- Primary completion
- 2027-08-31
- Completion
- 2028-08-31
- First posted
- 2023-05-03
- Last updated
- 2025-07-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05842057. Inclusion in this directory is not an endorsement.