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NCT06873581RECRUITINGIRB Ready

Pivotal Study of Voro Urologic Scaffold

(ARID II)

Sponsored by Levee Medical, Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 266 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

266 participants

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Gender

MALE

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Sponsor

Levee Medical, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
NOT_YET_RECRUITING

Sun City

Arizona

Location available
View Sun City location page
NOT_YET_RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
NOT_YET_RECRUITING

San Diego

California

Location available
View San Diego location page
NOT_YET_RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Indianapolis

Indiana

Location available
View Indianapolis location page
RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page
RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page

๐Ÿ“ And 11 more locations available

Frequently Asked Questions

Q: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.

Q: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.

Q: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.

Q: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.

Q: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.

Q: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.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Prostate Cancer Treatment in Tampa?

Join others in Florida exploring innovative treatment options through clinical research

Prostate Cancer Treatment Options in Tampa, Florida

If you're searching for Prostate Cancer treatment in Tampa, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Tampa, Indianapolis, Baltimore and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Prostate Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Florida
Now Enrolling
Up to 266 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Prostate Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Prostate Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Prostate Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06873581. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.