A prospective study to evaluate the safety and effectiveness of steerable Ureteroscopic Renal Evacuation (SURE) using CVAC® Set. - NA

Calyxo, Inc.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•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)

•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®.

发起方

Calyxo, Inc.