Status: Recruiting
Pivotal Study of Voro Urologic Scaffold
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.
Participants needed: 266
Trial details
Phase: Phase 3Age: 45+Biological sex: MaleType: InterventionalSponsor: Levee Medical, Inc.Updated: Jun 23, 2026Locations: 19
Eligibility criteria
Male >= 45 years of age of any race and ethnic group [+6]
Malignant tumors with known bladder neck or urethral sphincter invasion or metas... [+28]