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

NCT ID: NCT07155005

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2029-09-30

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of SURE with the CVAC System compared to other therapeutic interventions for the removal of renal stones in subjects that are candidates for URS with laser lithotripsy.

Conditions

Urolithiasis; Stones, Kidney; Renal Stones; Kidney Stones

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

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.

PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

Intervention Type: PROCEDURE

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.

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

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.

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

Intervention Type: DEVICE

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.

URETEROSCOPY (URS) WITHOUT SUCTION

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.

URETEROSCOPY (URS) WITHOUT SUCTION

Intervention Type: PROCEDURE

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.

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

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.

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

Intervention Type: DEVICE

Group/Cohort 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.

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).

CVAC® SYSTEM

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

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

Group/Cohort 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.

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

URETEROSCOPY (URS) WITHOUT SUCTION

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.

Intervention Type: PROCEDURE

PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

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.

Intervention Type: PROCEDURE

Other Intervention Names

SURE; CVAC; FANS; DISS; URS; Dusting; Basketing; PCNL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Calyxo, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CP00007

Identifier Type: -

Identifier Source: org_study_id