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

ConditionsUrolithiasis Stones, Kidney Renal Stones Kidney Stones

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCalyxo, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Candidate for ureteroscopy with laser lithotripsy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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).
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.
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.
URETEROSCOPY (URS) WITHOUT SUCTION
Procedure/Surgery
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)
Procedure/Surgery
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 groups

1,000 Participants

are divided into 5 treatment groups

Group A: PERCUTANEOUS NEPHROLITHOTOMY (PCNL)1 intervention

Group B: DIRECT IN-SCOPE SUCTION (DISS) IN FLEXIBLE URETEROSCOPY (FURS)1 intervention

Group C: URETEROSCOPY (URS) WITHOUT SUCTION1 intervention

Group D: FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)1 intervention

Group E: CVAC® SYSTEM1 intervention

Trial outcomes

Primary outcomes

Residual Stone Volume (RSV)

Time frame

30-Day

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Calyxo, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: