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

Sponsor

Calyxo, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04519294

Collaborator

(none)

162

Enrollment

Locations

Arms

36.5

Anticipated Duration (Months)

20.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone Renal Stone Urolithiasis	Device: SURE Device: Standard Ureteroscopy (Basketing)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 16, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

SFR [30 days]
Stone Free Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Institute of Urology	Tucson	Arizona	United States	85704
2	Johns Hopkins	Baltimore	Maryland	United States	21287
3	New Jersey Urology	Voorhees	New Jersey	United States	08043
4	Prisma Health	Greenville	South Carolina	United States	29650
5	Urology Austin	Austin	Texas	United States	78654
6	Dell Medical School, The University of Texas at Austin	Austin	Texas	United States	78712
7	UT Southwestern Medical Center	Dallas	Texas	United States	75390
8	Urology of Virginia	Virginia Beach	Virginia	United States	23462

Sponsors and Collaborators

Calyxo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Calyxo, Inc.

ClinicalTrials.gov Identifier:

NCT04519294

Other Study ID Numbers:

CP00001

First Posted:

Aug 19, 2020

Last Update Posted:

Feb 17, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Kidney Calculi

Urolithiasis

Study Results

No Results Posted as of Feb 17, 2022