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NCT06873581: ARID II

Pivotal Study of Voro Urologic Scaffold

Recruiting now Phase 3 Last updated 30 March 2026
What this trial tests

Phase 3 trial testing Voro Urologic Scaffold in Radical Prostatectomy in 266 participants. Currently enrolling.

Timeline
18 April 2025
Primary endpoint
1 February 2027
1 February 2028

Quick facts

Lead sponsorLevee Medical, Inc.
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment266
Start date18 April 2025
Primary completion1 February 2027
Estimated completion1 February 2028
Sites20 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Levee Medical, Inc. — full company profile →

Who can join

45 and older, male only, with Radical Prostatectomy or Stress Urinary Incontinence (SUI). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Initial results with an absorbable urologic scaffold to mitigate early urinary incontinence following radical prostatectomy: the ARID study.
    Gahan JC, Espino G, Young M, Bodden E, et al · · 2026 · PMID 41546699 · DOI 10.1007/s00345-026-06186-7

Verify or expand the search:

Other trials of Voro Urologic Scaffold

Trials testing the same drug.

Other recruiting trials for Radical Prostatectomy

Currently open trials in the same condition.

Other Levee Medical, Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06873581.

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