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
• Interventions: Device: Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System

• 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).

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System	Steerable Ureteroscopic Renal Evacuation (SURE) with 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).

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