Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryopreserved Umbilical Cord Allograft | Biological | — | UNRESOLVED |
| Robot-Assisted Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CLARIX CORD 1K
- description
- They will receive adjunctive CLARIX® CORD 1K (Amniox Medical, Inc., Miami, FL) during Robot-Assisted Radical Prostatectomy (RARP).
- interventionNames
- Biological: Cryopreserved Umbilical Cord Allograft
- Procedure: Robot-Assisted Radical Prostatectomy
- type
- ACTIVE_COMPARATOR
- label
- Controls
- description
- They will undergo RARP without adjunctive CLARIX® CORD 1K.
- interventionNames
- Procedure: Robot-Assisted Radical Prostatectomy
Primary outcomes (3)
- measure
- Erectile function
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available