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

Calyxo

Status: Active, not recruiting

Conditions: Urolithiasis; Kidney Stone; Renal Stones

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06615713

CP00003

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System

Experimental group

Description:

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).

Treatment:

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