Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy

Kidney Stones Clinical Trial

Official title:

Post FDA-Approval Clinical Evaluation of BackStopTM in Patients Undergoing Ureteroscopic Lithotripsy: A Prospective, Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02122341
• Other study ID #: HS-12-00714
• Status: Terminated
• Phase: N/A
• Start date: April 2014
• Est. completion date: July 2016

Study information

• Verified date: April 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Intervention

Device:
• BackStop
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).

Locations

Country	Name	City	State
United States	USC Institute of Urology	Los Angeles	California
United States	Urology of Virginia	Virginia Beach	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Urology of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (8)

Chow GK, Patterson DE, Blute ML, Segura JW. Ureteroscopy: effect of technology and technique on clinical practice. J Urol. 2003 Jul;170(1):99-102. — View Citation

Hendrikx AJ, Strijbos WE, de Knijff DW, Kums JJ, Doesburg WH, Lemmens WA. Treatment for extended-mid and distal ureteral stones: SWL or ureteroscopy? Results of a multicenter study. J Endourol. 1999 Dec;13(10):727-33. — View Citation

International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. — View Citation

Knispel HH, Klän R, Heicappell R, Miller K. Pneumatic lithotripsy applied through deflected working channel of miniureteroscope: results in 143 patients. J Endourol. 1998 Dec;12(6):513-5. — View Citation

Pardalidis NP, Kosmaoglou EV, Kapotis CG. Endoscopy vs. extracorporeal shockwave lithotripsy in the treatment of distal ureteral stones: ten years' experience. J Endourol. 1999 Apr;13(3):161-4. — View 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. — View Citation

Robert M, Bennani A, Guiter J, Avérous M, Grasset D. Treatment of 150 ureteric calculi with the Lithoclast. Eur Urol. 1994;26(3):212-5. — View Citation

Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn RI, Lingeman JE, Macaluso JN Jr. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol. 1997 Nov;158(5):1915-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need for Secondary Procedures	Need for secondary procedures of patients who had stone migration	Up to 3 months
Other	Time for BackStop Injection	Time required to deliver BackStop beginning with insertion of BackStop catheter and ending with its removal subsequent to the delivery of BackStop	Minutes during Surgery
Other	Duration of Lithotripsy Procedure	Duration of Lithotripsy Procedure	during surgery
Primary	Rate of Prevention of Retrograde Stone or Stone Fragment Migration	Prevention of retrograde stone migration (Yes/No)	At the time of surgery
Secondary	Stone-free Rate	Presence or absence of residual stone fragments at 2 month follow up after lithotripsy	2 months

External Links

•   FDA MAUDE database online (accessed date July 8, 2007)