NCT06873581 · Levee Medical, Inc.
Pivotal Study of Voro Urologic Scaffold
(ARID II)
What this study is about
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 treatment group$1. The study is a multi-center, single blind, randomly assigned, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States.
View original scientific 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.
Interventions
DEVICE
Voro Urologic Scaffold
The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.
Primary outcome measures
Number of participants with adverse events (AEs)
Time frame: Upto 24 months
AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants during the course of the study, whether or not related to the investigational device.
Number of Participants With Adverse Events Categorized by Severity
Time frame: Upto 24 months
The severity of adverse events as assessed by the investigator; events will be based on the definitions outlined in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy
Time frame: At 6 weeks post-prostatectomy
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 provide written consent to participate in the study 6. Able and willing to comply with study follow-up visits and procedures 7. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study
Exclusion criteria
- 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) 2. History of urinary incontinence, including stress or urge urinary incontinence 3. Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes 4. Currently treated with medications to treat overac
Where
- Phoenix, Arizona
- Sun City, Arizona
- Los Angeles, California
- San Diego, California
- Tampa, Florida
- Chicago, Illinois
- Indianapolis, Indiana
- Baltimore, Maryland
- Jackson, Mississippi
- New Hyde Park, New York
- New York, New York
- Rochester, New York
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations