CTRI/2024/05/067809
Not yet recruiting
Phase 3
A prospective study to evaluate the safety and effectiveness of steerable Ureteroscopic Renal Evacuation (SURE) using CVAC® Set. - NA
Calyxo, Inc.0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: N202- Calculus of kidney with calculus of ureterHealth Condition 2: N288- Other specified disorders of kidney and ureter
- Sponsor
- Calyxo, Inc.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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;
Outcomes
Primary Outcomes
Not specified
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