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NCT Number: NCT07155005

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CVAC® SYSTEM

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).

Other names: SURE, CVAC

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

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.

Other names: FANS

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

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.

Other names: DISS

URETEROSCOPY (URS) WITHOUT SUCTION

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.

Other names: URS, Dusting, Basketing

Percutaneous Nephrolithotomy (PCNL)

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.

Other names: PCNL

Primary outcomes

  1. Residual Stone Volume (RSV)

    Time frame: 30-Day

Sponsors and collaborators

Lead sponsor

Calyxo, Inc.

Industry

Registry information

Official study title

Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Other Therapeutic Interventions for the Treatment of Renal Stones: a Prospective, Observational Trial

Acronym: SCORE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 4, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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