Double-J PLUS Postmarket Registry

Completed

• Conditions: Ureter Obstruction

• Registration Number: NCT04197583
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Study Start: 2020-02-19
• Primary Completion: 2023-01-16
• Study Completion: 2023-02-22
• Results First Submitted: 2023-08-17
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Results First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Implanted Stents Meeting the Technical Success Criteria	2 months to 15 Months	Technical success was defined as: a stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters.
Primary Safety Endpoint	2 months to 15 Months	Any Serious Adverse Device Effects

Secondary Outcome Measures

Name	Time	Method
Quality of Life - Patient-Reported Outcomes	Change From Index Procedure to Stent Removal Visit; Change From Index Procedure to Post Stent Removal Visit Stent Removal: Typically, within 2 weeks to < 365 days from Index Procedure Post-Stent Removal: Typically, 3 - 12 weeks from Stent Removal	Measurement System Patient Reported Outcomes Measurement Information System (PROMIS®) for subjects ≥18 years; * Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity 3a, score range for the change from Index procedure is -41.1 to 41.1; * Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference 6b, score range for the change from Index procedure is -37.3 to 37.3; Higher PROMIS score means worse quality of life
Stent Migration	2 months to 15 Months	Stent Migration: Confirmed via imaging

Trial Locations

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; 🇫🇷 St Gregoire, France

Nagoya City University Hospital; 🇯🇵 Nagoya City, Aichi, Japan