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

N/AActive Not RecruitingNCT06615713

Calyxo, Inc.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Stones Kidney Stone Urolithiasis

Interventions

Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC SystemDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Muljibhai Patel Urological Hospital

Nadiād, India

Outcomes

Primary Outcomes

Stone Clearance

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

Time frame: Day 1 and Day 30

Data from ClinicalTrials.gov

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