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
Hackensack Meridian Health
100 participants
Jan 30, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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
Exclusion Criteria10
- 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
Interventions
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.
Robot-Assisted Radical Prostatectomy (RARP) is the most common surgical technique used to treat clinically localized prostate cancer however robot-assisted radical prostatectomy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04263025