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Completed

NCT Number: NCT04197583

Double-J PLUS Postmarket Registry Study

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

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Key information

Conditions

Ureter Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Ureteral Diseases Ureteral Obstruction Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Boston Scientific Ureteral Stents, Urinary Diversion Stent

Device

A BSC Ureteral Stent is an implantable device that is used to restore flow of urine from the kidney to the bladder in obstructed ureters. A BSC Urinary Diversion Stent is an implantable device that is used to restore flow of urine from the kidney.

Primary outcomes

  1. Percentage of Implanted Stents Meeting the Technical Success Criteria

    Time frame: 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.

  2. Primary Safety Endpoint

    Time frame: 2 months to 15 Months

    Any Serious Adverse Device Effects

Secondary outcomes

  1. Quality of Life - Patient-Reported Outcomes

    Time frame: 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

  2. Stent Migration

    Time frame: 2 months to 15 Months

    Stent Migration: Confirmed via imaging

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2019
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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