Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study (SCORE)

Calyxo

Status: Not yet enrolling

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

Treatments: Device: CVAC® SYSTEM; Procedure: URETEROSCOPY (URS) WITHOUT SUCTION; Procedure: PERCUTANEOUS NEPHROLITHOTOMY (PCNL); Device: FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS); Device: DIRECT IN-SCOPE SUCTION (DISS) IN FLEXIBLE URETEROSCOPY (FURS)

Study type: Observational

Funder types: Industry

Identifiers

NCT07155005

CP00007

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the effectiveness and safety of Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System versus other commonly used renal-stone interventions.

Full description

Up to 25 sites, and up to 250 subjects will be prospectively enrolled for phase 1: CVAC and FANS cohorts.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidate for ureteroscopy with laser lithotripsy or PCNL for the treatment of renal stones
• 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
• Visual evidence of infection at the time of the index procedure
• History of sepsis
• Significant comorbidities
• Bladder, ureteral or kidney abnormalities
• Pregnant individuals
• Unable to meet the treatment and follow up protocol requirements

Trial design

1,000 participants in 5 patient groups

PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

Description:

This is a surgical procedure under general anesthesia, where a rigid probe is placed through the flank, creating a percutaneous tract into the renal collecting system under fluoroscopy. Via nephoscopy, stones are fragmented, pulverized, and extracted.

Treatment:

Procedure: PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

DIRECT IN-SCOPE SUCTION (DISS) IN FLEXIBLE URETEROSCOPY (FURS)

Description:

DISS is a system that integrates controlled suction into the working channel of a standard flexible ureteroscope during ureteroscopic lithotripsy. A suction adapter is attached externally to the ureteroscope's working port, which connects to a standard hospital suction source.

Treatment:

Device: DIRECT IN-SCOPE SUCTION (DISS) IN FLEXIBLE URETEROSCOPY (FURS)

URETEROSCOPY (URS) WITHOUT SUCTION

Description:

URS allows the surgeon to visualize the stone by inserting the ureteroscope into the ureter, most often a flexible scope that allows them to accommodate to the shape of the ureter and renal collecting system. A laser fiber is advanced through the working channel of the ureteroscope to perform stone fragmentation (dusting or breaking up the calculi). Once the stones are dusted or fragmented, the pieces can be removed by active extraction of individual stone fragments using a retrieval basket or using the concept of stone dusting where the fragments are small enough to be passed after the procedure.

Treatment:

Procedure: URETEROSCOPY (URS) WITHOUT SUCTION

FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)

Description:

FANS is designed to incorporate suction to facilitate stone fragment removal through its lumen and is used with a separate ureteroscope. FANS is fitted with a Y connector with a pressure control vent and connects to a standard vacuum device. A separate ureteroscope provides direct visualization and irrigation and a separate specimen collector captures stone debris.

Treatment:

Device: FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)

CVAC® SYSTEM

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: CVAC® SYSTEM