Pivotal Study of Voro Urologic Scaffold
Recruiting
Phase 3
Interventional Study
Radical Prostatectomy
Stress Urinary Incontinence (SUI)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 45 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 266 (estimated)
- Sponsor
- Levee Medical, Inc. · Industry
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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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male \>= 45 years of age of any race and ethnic group
2. Diagnosed with prostate cancer and scheduled for radical prostatectomy
3. Gleason Grade Group 4 or lower
4. Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)
5. Able and willing to provid…
Contacts