Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
NCT ID: NCT05842057
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
118 participants
INTERVENTIONAL
2023-08-24
2028-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy
NCT06152146
Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma
NCT05687019
Stem Cells for Erectile Dysfunction Post RALP
NCT07048314
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy
NCT05363644
Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy
NCT00090376
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Membrane Arm: dHACM Group
Participants will undergo standard of care robot-assisted radical prostatectomy (RARP) surgery and the dehydrated Human Amnion Chorion Membrane (dHACM) membrane placed after removal of the prostate. Participants will be in the group for approximately 12 months.
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.
Control Arm: No dHACM Group
Participants will undergo standard of care RARP surgery but will have no dehydrated Human Amnion Chorion Membrane (dHACM) placed after removal of the prostate. Participants will be in the group for approximately 12 months.
Robot-Assisted Radical Prostatectomy
Robot-assisted surgical removal of the prostate, administered standard of care.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Men with baseline EPIC26 scores \< 50.
3. Patients with complete, bilateral nerve resection.
4. Previous treatment for prostate cancer.
5. Previous history of pelvic radiation.
6. Patients with impaired decision-making capacity.
40 Years
80 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Integra LifeSciences Corporation
INDUSTRY
University of Miami
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sanoj Punnen, MD, MAS
Associate Professor of Clinical
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sanoj Punnen, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20220852
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.