Pivotal Study of Voro Urologic Scaffold
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age45+
SponsorLevee Medical, Inc.
About this trial
The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm.
The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.
Eligibility criteria
Qualifiers
Male >= 45 years of age of any race and ethnic group
Diagnosed with prostate cancer and scheduled for radical prostatectomy
Gleason Grade Group 4 or lower
Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)
Disqualifiers
Malignant tumors with known bladder neck or urethral sphincter invasion or metastatic disease confirmed via baseline assessments (example [e.g.,] Multiparametric magnetic resonance imaging [mpMRI], bone scan)
History of urinary incontinence, including stress or urge urinary incontinence
Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes
Currently treated with medications to treat overactive bladder (OAB)
Trial design
Treatments tested in this trial
- Voro Urologic Scaffold
Treatment groups
266 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov