Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

NCT ID: NCT00893282

Last Updated: 2009-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. It is a water soluble polymer with reverse thermosensitive properties; the polymer exists as a liquid at low temperature (below 17 C) and rapidly transitions to a high viscosity gel at body temperature (i.e. in the ureter). BackStop is injected above the stones in the ureter and is intended to prevent retrograde migration of stones during ureteroscopic lithotripsy. Upon completion of the lithotripsy procedure, BackStop dissolves naturally or by irrigation.

The study hypothesis is that a greater proportion of patients will experience no retropulsion of a kidney stone when BackStop is used versus no anti-retropulsion device when undergoing intracorporeal lithotripsy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Calculi Kidney Stones

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BackStop

Intracorporeal lithotripsy with the use of an anti-retropulsion device.

Group Type EXPERIMENTAL

BackStop

Intervention Type DEVICE

BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.

Control

No anti-retropulsion device will be used during lithotripsy.

Group Type ACTIVE_COMPARATOR

Intracorporeal lithotripsy without the use of an anti-retropulsion device

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BackStop

BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.

Intervention Type DEVICE

Intracorporeal lithotripsy without the use of an anti-retropulsion device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient with a solitary, radio-opaque ureteral stone in the proximal ureter.
* Clinical indication for treatment by ureteroscopic lithotripsy.
* Minimum 18 years old (or any institutional age limits for participation in clinical study).
* Patients must be willing and able to participate in any follow-up visits, as required.
* Patients must provide informed consent.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pluromed, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pluromed, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McGill University Health Center

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BSTP-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lithotripsy for the Treatment of Gallstones
NCT00042549 TERMINATED PHASE4
Ultrasound Imaging of Kidney Stones and Lithotripsy
NCT02214836 ACTIVE_NOT_RECRUITING NA
HoYAG vs TFL in miniPCNL With ClearPetra
NCT07087977 NOT_YET_RECRUITING NA
CaOx Stone Prevention
NCT07225764 RECRUITING PHASE4