AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft (NCT04263025)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (11 items).
Location: Hackensack University Medical Center — Hackensack, New Jersey
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Previous history of pelvic radiation
- Previous history of simple prostatectomy or transurethral prostate surgery
- Previous history of systemic therapy for prostate cancer
- Patient has neurogenic bladder
- Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
- History of open pelvic surgery within 5 years except for hernia repair
- Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
- Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Hackensack University Medical Center — Hackensack, New Jersey
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.