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

NCT04263025 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-22

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Michael Stifelman, MD · Chair of Urology Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2027-04-01
Completion
2027-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04263025 on ClinicalTrials.gov