Health Condition 1: N202- Calculus of kidney with calculus of ureter Health Condition 2: N288- Other specified disorders of kidney and ureter
Conditions
Interventions
Intervention1: steerable ureteral catheter [CVACâ?¯Aspiration System]: Total duration of intervention is 4 Weeks.
Flexible steerable ureteral catheter employing ureteroscopy with irrigation and vacuum
Sponsors
Calyxo, Inc.
Veeda Clinical Research Limited
Eligibility
Inclusion criteria
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
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 â??tight ? ureter); 9. Ipsilateral impacted ureteral stone (not to include proximal ureter or ureteropelvic junction â??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®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The secondary endpoints are listed below. 1. Stone clearance at post-op day (POD) 30 2. Stone Free Rate (SFR) at post-op day (POD) 1 and (POD) 30 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) | — |
Countries
India
Contacts
Public ContactDr Ajay Gangoli
Muljibhai Patel Society for Research in Nephro-Urology
Outcome results
None listed