NCT04519294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

June 16, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
9 months until next milestone

Results Posted

Study results publicly available

January 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

August 17, 2020

Results QC Date

December 10, 2025

Last Update Submit

February 6, 2026

Conditions

Kidney StoneRenal StoneUrolithiasis

Outcome Measures

Primary Outcomes (1)

  • Stone Free Rate (SFR) - Zero Fragments

    The primary efficacy endpoint is the SFR, where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (1.25mm slice thickness) by blinded central reviewer(s). The SFR is calculated by determining the number of subjects in each treatment arm with a stone free status of zero fragments and dividing that by the total number of subjects treated in the respective treatment arm.

    30 Days

Secondary Outcomes (2)

  • Residual Stone Volume (RSV)

    30 Days

  • Stone Clearance (% Reduction in Stone Volume)

    30 Days

Study Arms (2)

SURE

ACTIVE COMPARATOR
Device: SURE

Standard Ureteroscopy (Basketing)

ACTIVE COMPARATOR
Device: Standard Ureteroscopy (Basketing)

Interventions

SUREDEVICE

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.

SURE
Standard Ureteroscopy (Basketing)DEVICE

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.

Standard Ureteroscopy (Basketing)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Arizona Institute of Urology

Tucson, Arizona, 85704, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

New Jersey Urology

Voorhees Township, New Jersey, 08043, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Prisma Health

Greenville, South Carolina, 29650, United States

Location

Urology Austin

Austin, Texas, 78654, United States

Location

Dell Medical School, The University of Texas at Austin

Austin, Texas, 78712, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Conditions

Kidney CalculiNephrolithiasisUrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jacqueline Welch
Organization
Calyxo, Inc.
info@calyxoinc.com
(925) 526-5900

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 19, 2020

Study Start

June 16, 2021

Primary Completion

January 30, 2023

Study Completion

April 30, 2025

Last Updated

February 27, 2026

Results First Posted

January 27, 2026

Record last verified: 2026-02

Locations

US(11)