Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology (TRUST)

Calyxo

Status: Not yet enrolling

Conditions: Urolithiasis; Kidney Stones; Renal Stones; Stones, Kidney

Treatments: Device: Standard Ureteroscopy (URS); Device: Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07101809

CP00006

Details and patient eligibility

About

The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.

Enrollment: 150 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
• Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)

Exclusion criteria

• Untreated urinary tract infection at the time of the index procedure
• Significant comorbidities
• Bladder, ureteral or kidney abnormalities
• Pregnant individuals
• Unable to meet the treatment and follow up protocol requirements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Standard Ureteroscopy (URS)

Active Comparator group

Description:

This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.

Treatment:

Device: Standard Ureteroscopy (URS)

Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System

Active Comparator 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) using the CVAC System