Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
Hackensack Meridian Health
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.
Description
One hundred male patients who are scheduled for bilateral, nerve-sparing RARP that meet the eligibility criteria will be enrolled. These patients will be equally randomized (1:1) into two groups (n=50/group): one group will receive adjunctive CLARIX® CORD 1K (Amniox Medical, Inc., Miami, FL) during RARP, while the other group will undergo RARP without adjunctive CLARIX® CORD 1K. Subject stratification will be performed based on the surgeon that will be performing the RARP. All patients will be given the same routine preoperative, perioperative and postoperative evaluation and care aside from t…
Eligibility
- Age range
- 30–70 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Male aged between 30 and 70 years old 2. Primary diagnosis of organ confined prostate cancer 3. Scheduled to undergo bilateral, nerve-sparing RARP 4. Patient has ICIQ-SF score \<6 5. Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26) 6. Patient is willing to return for all visits as defined in the protocol 7. Patient is willing to follow the instruction of the Investigator 8. Patient has provided written informed consent Exclusion Criteria: 1. Previous history of pelvic radiation 2. Previous history of simple prostatectomy or transurethral prostate sur…
Interventions
- BiologicalCryopreserved Umbilical Cord Allograft
CLARIX® CORD 1K (Amniox Medical, Miami, FL) is an umbilical cord allograft processed using the patented CRYOTEK™ process by TissueTech Inc. to devitalize all living cells but retain the natural structural and biological characteristics relevant to this tissue \[43\]. CLARIX® CORD 1K (6x3 cm in size) will be cut into two longitudinal pieces (1.5 cm in width) and placed circumferentially around each NVB as a nerve wrap during RARP. CLARIX® CORD 1K has been in market since 2013 in the United States as a "361 human cell and tissue-based product (HCT/P)" and is aseptically processed in compliance with current Good Tissue Practices (cGTP) as outlined in 21 CFR Part 1271.
- ProcedureRobot-Assisted Radical Prostatectomy
Robot-Assisted Radical Prostatectomy (RARP) is the most common surgical technique used to treat clinically localized prostate cancer however robot-assisted radical prostatectomy
Location
- Hackensack University Medical CenterHackensack, New Jersey