This study is in progress, not accepting new patients

A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System

a study on Kidney Stones

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Roger Sur, MD (ucsd)
Headshot of Roger Sur
Roger Sur

Description

Summary

This is a retrospective, multi-center collaboration to assess real-world outcomes of a novel steerable aspiration system, the CVAC® System ("CVAC"), and flexible and navigable suction ureteral access sheath (FANS) for the treatment of urinary stones.

Details

The objective of this study is observation of the safety and efficacy of subjects who underwent SURE procedure using the CVAC System or FANS for the removal of kidney stones in candidates for URS with laser lithotripsy. Efficacy will be observed by reviewing stone free status on standard of care post-procedure imaging. Safety will be observed by reviewing procedural information and if subjects had urologic events leading to Emergency Department (ED) visits, hospitalization, or retreatment.

Keywords

Urolithiasis, Kidney Stone, Kidney Stones, SURE, FANS, Kidney Calculi, CVAC® SYSTEM, FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subjects that had SURE procedure with CVAC System performed in the retrospective cohort
  • Subjects that had flexible URS (fURS) procedure with FANS performed in the retrospective cohort

You CAN'T join if...

  • For planned SURE procedures, the inability for CVAC to gain access required for treatment of kidney stones

Location

  • University of California San Diego (UCSD)
    La Jolla 5363943 California 5332921 92093-0934 United States

Lead Scientist at University of California Health

  • Roger Sur, MD (ucsd)
    * Seek role of urinary protein abnormalities (Tamm Horsfall Protein) in kidney stone disease. * Determine genetic causes of kidney stone disease. * Create a radiation free kidney stone center that provides novel, minimally invasive surgical techniques.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Calyxo, Inc.
ID
NCT07225933
Study Type
Observational
Participants
Expecting 3000 study participants
Last Updated