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OpenTrials
Completed

NCT Number: NCT06615713

CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones

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.

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Key information

Conditions

Renal Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stone Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muljibhai Patel Urological Hospital

Nadiād, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System

Device

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).

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Calyxo, Inc.

Industry

Registry information

Official study title

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

Acronym: CLEARANCE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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