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Trial Title:
Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
NCT ID:
NCT05842057
Condition:
Prostate Cancer
Erectile Dysfunction Following Radical Prostatectomy
Conditions: Official terms:
Erectile Dysfunction
Conditions: Keywords:
Prostatectomy
Allograft Membrane
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Care Provider)
Masking description:
Participants will be blinded to the treatment they receive. To minimize bias on the
surgical team during the nerve sparing process, the surgical team will be blinded to arm
allocation until after the prostate is removed.
Intervention:
Intervention type:
Biological
Intervention name:
BioDFence G3 Placental Tissue Membrane
Description:
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.
Arm group label:
Membrane Arm: dHACM Group
Other name:
Dehydrated Human Amnion Chorion Membrane (dHACM)
Other name:
Human Amnion Membrane Allograft
Intervention type:
Procedure
Intervention name:
Robot-Assisted Radical Prostatectomy
Description:
Robot-assisted surgical removal of the prostate, administered standard of care.
Arm group label:
Control Arm: No dHACM Group
Arm group label:
Membrane Arm: dHACM Group
Other name:
RARP
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral
nerve-sparing RARP at the University of Miami (UM).
Exclusion Criteria:
1. Men requiring any use of pads for urinary leakage.
2. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED)
3. Men with baseline EPIC26 scores < 60.
4. Previous treatment for prostate cancer.
5. Previous history of pelvic radiation.
6. Patients with impaired decision-making capacity.
Gender:
Male
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sanoj Punnen, MD, MAS
Phone:
305-243-3246
Email:
s.punnen@med.miami.edu
Contact backup:
Last name:
Elena M Cortizas
Phone:
305-243-6438
Email:
ecortizas@med.miami.edu
Investigator:
Last name:
Sanoj Punnen, MD, MAS
Email:
Principal Investigator
Start date:
August 24, 2023
Completion date:
August 31, 2028
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
Integra LifeSciences Corporation
Agency class:
Industry
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05842057
