Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
Status: Recruiting
Location: See location...
Intervention Type: Biological, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function after the surgery. As part of the study, the patient will be asked to answer various questions after the surgery regarding sexual and urinary function.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: f
View:
• Male aged between 30 and 70 years old
• Primary diagnosis of organ confined prostate cancer
• Scheduled to undergo bilateral, nerve-sparing RARP
• Patient has ICIQ-SF score \<6
• Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26)
• Patient is willing to return for all visits as defined in the protocol
• Patient is willing to follow the instruction of the Investigator
• Patient has provided written informed consent
Locations
United States
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Contact Information
Primary
Sharon Seidman, RN
Sharon.Seidman@hmhn.org
5519963749
Time Frame
Start Date: 2020-01-30
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 100
Treatments
Experimental: CLARIX CORD 1K
They will receive adjunctive CLARIX® CORD 1K (Amniox Medical, Inc., Miami, FL) during Robot-Assisted Radical Prostatectomy (RARP).
Active_comparator: Controls
They will undergo RARP without adjunctive CLARIX® CORD 1K.
Related Therapeutic Areas
Sponsors
Leads: Hackensack Meridian Health