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Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy

NCT02122341 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-05-22

Study results available
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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

Interventions

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).

Sponsors & Collaborators

  • Urology of Virginia

    collaborator OTHER

  • University of Southern California

    lead OTHER

Principal Investigators

  • Matthew Dunn, M.D. · USC Institute of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02122341 on ClinicalTrials.gov