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

Primary Purpose

Kidney Stone, Renal Stone, Urolithiasis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SURE
Standard Ureteroscopy (Basketing)
Sponsored by
Calyxo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic
  • Arizona Institute of Urology
  • Johns Hopkins
  • New Jersey Urology
  • Albany Medical College
  • Duke University
  • Prisma Health
  • Urology Austin
  • Dell Medical School, The University of Texas at Austin
  • UT Southwestern Medical Center
  • Urology of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SURE

Standard Ureteroscopy (Basketing)

Arm Description

Outcomes

Primary Outcome Measures

SFR
Stone Free Rate

Secondary Outcome Measures

Full Information

First Posted
August 17, 2020
Last Updated
March 3, 2023
Sponsor
Calyxo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04519294
Brief Title
Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calyxo, Inc.

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Renal Stone, Urolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SURE
Arm Type
Active Comparator
Arm Title
Standard Ureteroscopy (Basketing)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
SURE
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Ureteroscopy (Basketing)
Intervention Description
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.
Primary Outcome Measure Information:
Title
SFR
Description
Stone Free Rate
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Arizona Institute of Urology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
New Jersey Urology
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Urology Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78654
Country
United States
Facility Name
Dell Medical School, The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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