NCT04263025 AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
| NCT ID | NCT04263025 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Hackensack Meridian Health |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-01-30 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2020-01-30 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion 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 Exclusion Criteria: 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
Contact & Investigator
Michael Stifelman, MD
PRINCIPAL INVESTIGATOR
Chair of Urology Department
Frequently Asked Questions
Who can join the NCT04263025 clinical trial?
This trial is open to male participants only, aged 30 Years or older, up to 70 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04263025 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04263025 currently recruiting?
Yes, NCT04263025 is actively recruiting participants. Contact the research team at Sharon.Seidman@hmhn.org for enrollment information.
Where is the NCT04263025 trial being conducted?
This trial is being conducted at Hackensack, United States.
Who is sponsoring the NCT04263025 clinical trial?
NCT04263025 is sponsored by Hackensack Meridian Health. The principal investigator is Michael Stifelman, MD at Chair of Urology Department. The trial plans to enroll 100 participants.
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