Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Using the CVAC® System

Not Applicable

Active, not recruiting

• Conditions: Renal Stones; Kidney Stone; Urolithiasis

• Registration Number: NCT06615713
• Lead Sponsor: Calyxo, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-05
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-27
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Stone Clearance	Day 1 and Day 30	The stone clearance at Post-Op Day 1 (POD1) and Post-Op Day 30 (POD30) on non-contrast CT (NCCT)

Trial Locations

Locations (1)

Muljibhai Patel Urological Hospital; 🇮🇳 Nadiad, India