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RECRUITING
NCT04263025
PHASE2/PHASE3

AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

Sponsor: Hackensack Meridian Health

View on ClinicalTrials.gov

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.

Official title: Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

Key Details

Gender

MALE

Age Range

30 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2020-01-30

Completion Date

2027-04-01

Last Updated

2025-10-22

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Cryopreserved 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.

PROCEDURE

Robot-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

Locations (1)

Hackensack University Medical Center

Hackensack, New Jersey, United States