Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy

NCT02122341 | Terminated Results

• 1 other identifier: HS-12-00714
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Stones

Outcome Measures

Primary Outcomes (1)

• Rate of Prevention of Retrograde Stone or Stone Fragment Migration

  Prevention of retrograde stone migration (Yes/No)

  At the time of surgery

Secondary Outcomes (1)

• Stone-free Rate

  2 months

Other Outcomes (3)

• Need for Secondary Procedures

  Up to 3 months

• Time for BackStop Injection

  Minutes during Surgery

• Duration of Lithotripsy Procedure

  during surgery

Study Arms (2)

BackStop

EXPERIMENTAL

Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.

Device: BackStop

Control

NO INTERVENTION

Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.

Interventions

BackStop DEVICE

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).

BackStop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University of Southern California: lead
• Urology of Virginia: collaborator

Study Sites (2)

USC Institute of Urology

Los Angeles, California, 90089, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Related Publications (8)

• 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. doi: 10.1016/s0022-5347(01)64173-9.

  PMID: 9334635 BACKGROUND

• 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. No abstract available.

  PMID: 11590294 BACKGROUND

• 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. doi: 10.1089/end.1999.13.727.

  PMID: 10646679 BACKGROUND

• 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. doi: 10.1089/end.1999.13.161.

  PMID: 10360494 BACKGROUND

• 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. doi: 10.1097/01.ju.0000070883.44091.24.

  PMID: 12796655 BACKGROUND

• Knispel HH, Klan 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. doi: 10.1089/end.1998.12.513.

  PMID: 9895254 BACKGROUND

• Robert M, Bennani A, Guiter J, Averous M, Grasset D. Treatment of 150 ureteric calculi with the Lithoclast. Eur Urol. 1994;26(3):212-5. doi: 10.1159/000475382.

  PMID: 7805707 BACKGROUND

• 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.

  PMID: 20171695 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was not able to meet target accrual and was closed early. More patients are needed to fully evaluate the clinical effectiveness of BackStop.

Results Point of Contact

• Title: Dr. Matthew Dunn
• Organization: USC Intitute of Urology

mdunn@med.usc.edu

323-865-3700

Study Officials

• Matthew Dunn, M.D.

  USC Institute of Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 24, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 22, 2019
• Results First Posted: May 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)