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Double-J PLUS Postmarket Registry Study | Clinical Trials | Clareo Health

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Double-J PLUS Postmarket Registry Study

Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry

NCT04197583•Boston Scientific Corporation

Summary

A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents

Detailed Description

A multi-center registry study to obtain post-market clinical data on safety and effectiveness of the Boston Scientific Ureteral and Urinary Diversion Stents

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is undergoing placement of a Boston Scientific Ureteral Stent
•Subject anatomy is appropriate to accommodate a stent size available in the study
•Subject is able to accurately detect and report bladder function and pain
•Subject is willing and able to:
•* Complete patient QoL questionnaire at specified time points (for subjects aged ≥ 18 years)
•* Return for all follow-up visits
•Subject is undergoing placement of a Boston Scientific Urinary Diversion Stent(s)
•The anatomical features of the involved renal collecting system are known by either prior or concurrent urography or axial CT imaging
•Subject is willing and able to return for all follow-up visits

Exclusion Criteria

•Subjects who meet any of the contraindications per individual stent DFU
•Subjects receiving different stent type in case of bilateral/multiple stenting
•Subjects with an indwelling ureteral stent(s) not planned to be removed prior to/or concurrently with the study stent implant

Locations (10)

Mayo Clinic Phoenix

Phoenix, Arizona, United States

Northwestern University-Department of Urology

Chicago, Illinois, United States

NorthShore University HealthSystem

Glenview, Illinois, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Vancouver General Hospital

Vancouver, British Columbia, Canada

Centre Hospit Prive St Gregoire Vivalto

Saint-Grégoire, France

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Key Dates

Start Date

February 19, 2020

Primary Completion Date

January 16, 2023

Completion Date

February 22, 2023

Last Updated

March 3, 2026

Enrollment

379

ACTUAL participants

Conditions

Ureter Obstruction

Interventions

Boston Scientific Ureteral Stents, Urinary Diversion Stent

DEVICE

Is it Safe to Advance a Guidewire Through a Previously Placed Double j Stent?

NCT05265936

Kidney StoneUreter Obstruction+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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