AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft (NCT04263025) | Clinical Trial Compass
RecruitingPhase 2/3
AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
United States100 participantsStarted 2020-01-30
Plain-language 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.
Who can participate
Age range30 Years – 70 Years
SexMALE
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Inclusion criteria
✓. 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 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