Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy
NCT ID: NCT02122341
Last Updated: 2019-05-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
35 participants
INTERVENTIONAL
2014-04-30
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy
NCT00893282
Evaluation of Ureteral Stents in the Management of Stone Disease
NCT02211313
The RELIEF™ Ureteral Stent Randomized Controlled Trial
NCT06720740
Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
NCT06942949
Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
NCT00199524
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BackStop
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
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).
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Urology of Virginia
OTHER
University of Southern California
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthew Dunn, M.D.
Role: PRINCIPAL_INVESTIGATOR
USC Institute of Urology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
USC Institute of Urology
Los Angeles, California, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
FDA MAUDE database online (accessed date July 8, 2007)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HS-12-00714
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.