CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones

NCT06615713 | Completed Results FDA Device

• 1 other identifier: CP00003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Stones; Kidney Stone; Urolithiasis

Outcome Measures

Primary Outcomes (3)

• Stone Clearance (% Reduction in Stone Volume)

  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)

  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

  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

Study Arms (1)

Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System

EXPERIMENTAL

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

Interventions

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).

Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Calyxo, Inc.: lead

Study Sites (1)

Muljibhai Patel Urological Hospital

Nadiād, India

Location

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological 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: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: September 5, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Locations

IN (1)