Clinical trial NCT02122341: Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy
Official title: Post FDA-Approval Clinical Evaluation of BackStopTM in Patients Undergoing Ureteroscopic Lithotripsy: A Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Stones
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Urology of Virginia
First posted: 2014-04-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: During ureteroscopic treatment for ureteral stones, lithotripsy, irrigation, and manipulation of the stone often pushes stone away into the kidney itself. This phenomenon is called retropulsion, which is defined as clinically significant retrograde migration of stone or stone fragments. Movement of stones retrograde into the renal pelvis could potentially add and complicate the surgery further. Often scopes need to be changed in order to reach the stone, and chasing these stones will add time to the surgery and require more valuable resources. Furthermore, sometimes a second operation will need to be done when these retropulsed fragments could not be all found and cleaned out.

A number of devices have been developed to prevent such migration including stone baskets and conical devices. These are wire-based devices which have the potential of injuring the ureter. Because of safety concerns and that there is limited data available on the effectiveness of these devices; these are not widely used by urologists. BackStop has recently been developed as another tool to prevent retropulsion. It is a water soluble gel that is injected proximal to the stone. This creates a physical barrier that prevents stone migration during ureteroscopic lithotripsy for ureteral calculus.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of Prevention of Retrograde Stone or Stone Fragment Migration
timeFrame: At the time of surgery
Secondary outcomes:
measure: Stone-free Rate
timeFrame: 2 months
Other outcomes:
measure: Need for Secondary Procedures
timeFrame: Up to 3 months
measure: Time for BackStop Injection
timeFrame: Minutes during Surgery
measure: Duration of Lithotripsy Procedure
timeFrame: during surgery
Locations:
city: Los Angeles
country: United States
facility: USC Institute of Urology
state: California
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
Study officials:
affiliation: USC Institute of Urology
name: Matthew Dunn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rane A, Bradoo A, Rao P, Shivde S, Elhilali M, Anidjar M, Pace K, D'A Honey JR. The use of a novel reverse thermosensitive polymer to prevent ureteral stone retropulsion during intracorporeal lithotripsy: a randomized, controlled trial. J Urol. 2010 Apr;183(4):1417-21. doi: 10.1016/j.juro.2009.12.023. Epub 2010 Feb 20.