CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones (CLEARANCE)

April 7, 2026 updated by: Calyxo, Inc.

A Prospective Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Using the CVAC® Set

The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • India
      • Nadiād, India
        • Muljibhai Patel Urological Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Candidate for ureteroscopy with laser lithotripsy;
  • Be willing and able to return for and respond to all study-related follow up procedures; and,
  • Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF).

Exclusion Criteria:

  • Significant morbidities;
  • Unable to meet the treatment and follow up protocol requirements; and,
  • Ureteral or kidney abnormalities.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
Device: Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone Clearance (% Reduction in Stone Volume)
Time Frame: 30 Days

The percent reduction ([Baseline stone volume- 30-Day stone volume] / Baseline stone volume) in stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness).

A positive result indicates a decrease in stone volume removed during the procedure; a negative value indicates an increase in stone volume following the procedure.
30 Days
Residual Stone Volume (RSV)
Time Frame: 30 Days
A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness).
30 Days
Stone Free Rate (SFR) - Zero Fragments
Time Frame: 30 Days
Where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (2.0mm slice thickness). SFR is calculated by determining the number of kidneys in each treatment arm with a stone free status of zero fragments and dividing that by the total number of kidneys treated in the respective treatment arm.
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)

September 5, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP00003

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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