Actively Recruiting
AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
Led by Hackensack Meridian Health · Updated on 2025-10-22
100
Participants Needed
1
Research Sites
374 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged between 30 and 70 years old
- Primary diagnosis of organ confined prostate cancer
- Scheduled to undergo bilateral, nerve-sparing robot-assisted radical prostatectomy
- Patient has ICIQ-SF score less than 6
- Patient has no erectile dysfunction (IIEF-6 score 26 or higher)
- Willing to return for all visits as defined in the protocol
- Willing to follow the instructions of the Investigator
- Provided written informed consent
You will not qualify if you...
- Previous history of pelvic radiation
- Previous history of simple prostatectomy or transurethral prostate surgery
- Previous history of systemic therapy for prostate cancer
- Neurogenic bladder
- Body weight less than 50 kg (110 pounds) or body mass index greater than 40 kg/m2
- History of open pelvic surgery within 5 years except for hernia repair
- Scheduled to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
- Any neurologic or psychiatric disorder that might affect post-surgical assessments
- Received investigational drug within 30 days prior to study or planned administration of another investigational product during study
- Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin-B
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
S
Sharon Seidman, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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