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NCT04263025Active, not recruitingPhase 2/3

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

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

Source: ClinicalTrials.gov · Last updated 26 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
100 (actual)
First submitted
7 Feb 2020
Start date
30 Jan 2020
Primary completion date
1 Apr 2027
Lead sponsor
Hackensack Meridian Health
NCT number
NCT04263025

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 100
  • From 30 Jan 2020 to the primary completion date, 1 Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of pelvic radiation
  • Previous history of simple prostatectomy or transurethral prostate surgery
  • Previous history of systemic therapy for prostate cancer
  • Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
  • Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
  • Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

Other illness

  • History of open pelvic surgery within 5 years except for hernia repair
  • Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments

Other

  • Patient has neurogenic bladder
  • Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2

Who the study is looking for

  • 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

Age in the registry: 30 years to 70 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.