The clinical investigation study of steerable ureteral catheter system for the treatment and removal of urinary stones (kidney stones, fragments, and dust).

Phase 3

Conditions: Health Condition 1: N202- Calculus of kidney with calculus of ureterHealth Condition 2: N288- Other specified disorders of kidney and ureter

Registration Number: CTRI/2024/05/067809

Lead Sponsor: Calyxo, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. = 18 years of age;

2. Candidate for ureteroscopy with laser lithotripsy;

3. Total renal stone burden of 7 mm - 30 mm as measured by the sum of the longest dimension from the axial, coronal or sagittal view (whichever is longest) of each stone on CT within 90 days before the index procedure;

4. Be willing and able to return for and respond to all study-related follow up procedures; and,

5. Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF)

Exclusion Criteria

1. Significant morbidities that in the opinion of the Investigator, could represent an increased perioperative risk for the subject;

2. Challenging renal anatomy that does not allow for initiation of SURE;

3. Ipsilateral partial nephrectomy within 6 months prior to index procedure;

4. History of ipsilateral ureteral reimplantation or ureteral reconstruction;

5. Simple or radical prostatectomy within 6 months prior to index procedure;

6. History of urinary diversion;

7. Ureteral ipsilateral stricture, untreated;

8. Ureteral stricture, untreated (not to include tight ? ureter);

9. Ipsilateral impacted ureteral stone (not to include proximal ureter or ureteropelvic junction UPJ ? stones);

10. Medullary sponge kidney;

11. Renal insufficiency requiring dialysis at the time of screening;

12. Bleeding diathesis (anticoagulants that cannot be discontinued); and

13.Any subjects with intraoperative complications, i.e., ureteral trauma, prior to introduction of CVAC®.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the stone clearance, defined as percent reduction in stone volume. At post-op day (POD) 1 on NCCT by independent reviewer.Timepoint: baseline, 1 day & 4 weeks

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are listed below. <br/ ><br>1. Stone clearance at post-op day (POD) 30 <br/ ><br>2. Stone Free Rate (SFR) at post-op day (POD) 1 and (POD) 30 <br/ ><br>3. Residual stone volume at post-op day (POD) 1 and post-op day (POD) 30Timepoint: baseline and post-op day (POD) 1 and POD 30 non-contrast CT (NCCT)