Recruiting

SURE vs. Interventions

Sponsor:

Calyxo, Inc.

Code:

NCT07155005

Conditions

Urolithiasis

Stones, Kidney

Renal Stones

Kidney Stones

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CVAC® SYSTEM

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

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

URETEROSCOPY (URS) WITHOUT SUCTION

PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

Study Details

Brief summary:

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.

Conditions

Urolithiasis

Stones, Kidney

Renal Stones

Kidney Stones

Study ID

NCT07155005

Start date

Oct 12, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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).

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).

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.

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.

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.

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.

Primary outcome measure

  • Residual Stone Volume (RSV) [ Time Frame: 30-Day ]

Central Contacts and Locations

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Laura Angulo Llanos, MD

305-243-4850lxa2084@med.miami.edu

Wichita Urology Group

Recruiting

Wichita, Kansas, United States, 67226

Contacts

University of Buffalo

Recruiting

Cheektowaga, New York, United States, 14225

Contacts

Integrated Medical Professionals (IMP)

Recruiting

New York, New York, United States, 10016

Contacts

Northwell Health

Recruiting

New York, New York, United States, 10075

Contacts

Urology Specialists of the Carolinas (USOC)

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

The Urology Group

Recruiting

Cincinnati, Ohio, United States, 45212

Contacts

Urology Specialists of South Dakota

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

Urology Partners of North Texas

Recruiting

Arlington, Texas, United States, 76017

Contacts

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

More Information

Sponsor

Calyxo, Inc.

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Keywords

  • ureteroscopy
  • CVAC
  • SURE
  • URS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Calyxo, Inc. on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.