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

Description

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

Prostate Cancer

Study Overview

Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Hackensack

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Previous history of pelvic radiation
  • 2. Previous history of simple prostatectomy or transurethral prostate surgery
  • 3. Previous history of systemic therapy for prostate cancer
  • 4. Patient has neurogenic bladder
  • 5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
  • 6. History of open pelvic surgery within 5 years except for hernia repair
  • 7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
  • 8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments
  • 9. 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
  • 10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

Ages Eligible for Study

30 Years to 70 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hackensack Meridian Health,

Michael Stifelman, MD, PRINCIPAL_INVESTIGATOR, Chair of Urology Department

Study Record Dates

2025-10-01