Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy

Stopped early · Not applicable

Conditions studied: Kidney Stones

In brief

The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.

Key facts

Study ID: NCT02122341
Run by: University of Southern California
People needed: 35
Starts: 2014-04-01
Expected to finish: 2016-07-01
Last updated by the study team: 2019-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

patient with solitary ureteral stone ranging from 5mm to 15mm diameter
able to tolerate general anesthesia
clinical indication for treatment by ureteroscopic lithotripsy
must be willing and able to participate in any follow-up visits
provide informed consent
have a CT scan demonstrating the stone

You may not qualify if…

patients undergoing extracorporeal shock wave lithotripsy (ESWL) or any other extracorporeal or percutaneous lithotripsy procedure as primary procedure
any co-morbidity or condition that would necessitate exclusion of patient (physician opinion)
renal or ureteral anatomical abnormality
multiple stones in the indicated ureter
stones in the indicated kidney
patient is immunocompromised
multiple organ dysfunction syndrome
has an absolute or relative solitary kidney mass
>= Stage 3 chronic kidney disease
bilateral ureteral obstructing stones
staghorn calculi
impaction of several stone fragments (Steinstrasse)
uncorrected coagulopathy/thrombocytopenia
urethral and/or ureteral stricture
reconstructive urinary surgery

Where it is running

USC Institute of Urology — Los Angeles, California, United States
Urology of Virginia — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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