Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)

March 3, 2023 updated by: Calyxo, Inc.

A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy

The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
      • Tucson, Arizona, United States, 85704
        • Arizona Institute of Urology
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • New Jersey Urology
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • South Carolina
      • Greenville, South Carolina, United States, 29650
        • Prisma Health
    • Texas
      • Austin, Texas, United States, 78654
        • Urology Austin
      • Austin, Texas, United States, 78712
        • Dell Medical School, The University of Texas at Austin
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Candidate for ureteroscopy with laser lithotripsy;
  • Presence of renal stone(s);
  • Be willing and able to return for all study-related follow up procedures; and,
  • Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.

Exclusion Criteria:

  • BMI > 45;
  • Significant comorbidities;
  • Bladder, ureteral or kidney abnormalities;
  • Pregnant individuals; or
  • Unable to meet the treatment and follow up protocol requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SURE
Device: SURE
The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones.
Active Comparator: Standard Ureteroscopy (Basketing)
Device: Standard Ureteroscopy (Basketing)
This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SFR
Time Frame: 30 days
Stone Free Rate
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calyxo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP00001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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