Pivotal Study of Voro Urologic Scaffold

Part of paid clinical trials in Phoenix, Arizona.

Sponsor: Levee Medical, Inc.
Study ID: NCT06873581
Phase: PHASE3
Status: Recruiting

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Conditions

Radical Prostatectomy
Stress Urinary Incontinence (SUI)

Eligibility Criteria

Sex: MALE
Age: 45 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Voro Urologic Scaffold — DEVICE
The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.

Study Details

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.

Key Dates

Start date: Apr 18, 2025
Status verified: May 2026
Primary completion: Apr 30, 2028
Completion: Apr 30, 2028

Study Design

Enrollment: 266 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Voro Urologic Scaffold Group
Participants will undergo robotic assisted radical prostatectomy procedure as part of their standard of care treatment for their prostate cancer. The Voro Urologic Scaffold will be placed during the prostatectomy procedure after prostate removal.
No Intervention: Control Group
Participants will undergo robotic assisted radical prostatectomy procedure as part of their standard of care treatment for their prostate cancer. This group will not receive Voro Urologic Scaffold during the treatment.

Primary Outcome Measure

Number of participants with adverse events (AEs) [ Time Frame: Upto 24 months ]

Central Contacts

Karen Cornett
919-313-4520
[email protected]

Locations (19)

Facility	City	State	ZIP	Site coordinators
Mayo Clinic	Phoenix	Arizona	85054	Revathy Vilasan [email protected] Scott Cheney, MD (PRINCIPAL_INVESTIGATOR)
Academic Urology	Sun City	Arizona	85351	Jennifer Hill [email protected] Jeff Stern, MD (PRINCIPAL_INVESTIGATOR)
University of California Los Angeles	Los Angeles	California	90095	Keyla Morales [email protected] Wayne Brisbane, MD (PRINCIPAL_INVESTIGATOR)
University of California San Diego	San Diego	California	92093	Dyhana Carrasco [email protected] Michael Liss, MD (PRINCIPAL_INVESTIGATOR)
Tampa General Hospital	Tampa	Florida	33606	Ray De La Morena [email protected] Trushar Patel, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medicine	Chicago	Illinois	60611	Suki Bristol [email protected] Abhinav Sidana, MD (PRINCIPAL_INVESTIGATOR)
IU school of Medicine, Department of Urology	Indianapolis	Indiana	46202	Brandon Garver [email protected] Michal Koch, MD (PRINCIPAL_INVESTIGATOR)
John Hopkins	Baltimore	Maryland	21287	Michael Ayenew [email protected] Arvin George, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland	Baltimore	Maryland	21201	Ganine Markowitz [email protected] Minhaj Siddiqui, MD (PRINCIPAL_INVESTIGATOR)
BMHCC/ Mississippi Urology Clinic	Jackson	Mississippi	39202	Greta Beatty [email protected] Jennie Mallory [email protected] Patrick Daily, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health	New Hyde Park	New York	11042	Cynthia Knauer [email protected] Lee Richstone, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Ryan Norton [email protected] James Eastham, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical Center	Rochester	New York	14620	Austin Jackson [email protected] Tom Frye, MD (PRINCIPAL_INVESTIGATOR)
Erlanger Urology	Chattanooga	Tennessee	37403	Christian Hughes [email protected] Amar Singh, MD (PRINCIPAL_INVESTIGATOR)
The Conrad Pearson Clinic	Germantown	Tennessee	38138	Russell S Grigsby [email protected] Adam Stewart, MD (PRINCIPAL_INVESTIGATOR)
Urology Associates PC Nashville	Nashville	Tennessee	37209	Robert Patton [email protected] Guatam Jayram, MD (PRINCIPAL_INVESTIGATOR)
Urology of Austin	Austin	Texas	78759	Liz Ayala [email protected] Brian Mazzarella, MD (PRINCIPAL_INVESTIGATOR)
Potomac Urology Center	Alexandria	Virginia	22311	Annelise Marsh [email protected] Aseem Malhotra, MD (PRINCIPAL_INVESTIGATOR)
Urology of Virginia, PLLC	Virginia Beach	Virginia	23462	Sabrina Delfenthal [email protected] Robert Given, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site

Mayo Clinic· Phoenix, AZ Academic Urology· Sun City, AZ University of California Los Angeles· Los Angeles, CA University of California San Diego· San Diego, CA Tampa General Hospital· Tampa, FL University of Chicago Medicine· Chicago, IL

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