Double-J PLUS Postmarket Registry

Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry

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

Study Overview

• Status: Completed
• Conditions: Ureter Obstruction
• Intervention / Treatment: Device: Boston Scientific Ureteral Stents, Urinary Diversion Stent

• Study Type: Observational
• Enrollment (Actual): 379

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
• France
  • St Gregoire, France, 35760
    • Centre Hospit Prive St Gregoire Vivalto
• Japan
  • Aichi
    • Nagoya City, Aichi, Japan, 467-8602
      • Nagoya City University Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Phoenix
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University-Department of Urology
    • Glenview, Illinois, United States, 60026
      • NorthShore University HealthSystem
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital-Columbia University Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Study will enroll patients who are receiving a Boston Scientific Ureteral stent or Urinary Diversion Stent as part of their standard of care.

Description

Inclusion Criteria (for all Ureteral stent types except Urinary Diversion Stents):

• 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

Inclusion Criteria (for Urinary Diversion Stents):

• 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 (for Ureteral stents and Urinary Diversion Stents):

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	For all stents other than Urinary Diversion Stents: Stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters. For Urinary Diversion Stent, drainage from the kidney following stent placement during the planned indwell time with no re-intervention for obstruction.	2 months to 12 Months
Primary safety endpoint	Any Serious Adverse Device Effects	2 months to 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life - Patient-Reported Outcomes	Measurement System (PROMIS®) for subjects ≥18 years; PROMIS Adult Short Form v1.0 - Pain Intensity 3a; PROMIS Adult Short Form v1.0 - Pain Interference 6b	2 months, 12 Months
Stent Migration	Stent Migration: Confirmed via imaging	2 months to 12 Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): February 22, 2023

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Ureteral Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Ureteral Obstruction
• Other Study ID Numbers: U0652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes