Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Post FDA-Approval Clinical Evaluation of BackStopTM in Patients Undergoing Ureteroscopic Lithotripsy: A Prospective, Randomized Clinical Trial|
- Rate of prevention of retrograde stone or stone fragment migration [ Time Frame: At the time of surgery ]
- Stone-free rate [ Time Frame: 2 months ]
- Need for secondary procedures [ Time Frame: Up to 3 months ]
- Time for BackStop injection [ Time Frame: During Surgery ]
- Duration of lithotripsy procedure [ Time Frame: during surgery ]
|Study Start Date:||April 2014|
|Study Completion Date:||July 2016|
|Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.
BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
No Intervention: Control
Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02122341
|United States, California|
|USC Institute of Urology|
|Los Angeles, California, United States, 90089|
|United States, Virginia|
|Urology of Virginia|
|Virginia Beach, Virginia, United States, 23462|
|Principal Investigator:||Matthew Dunn, M.D.||USC Institute of Urology|