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Double-J PLUS Postmarket Registry

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04197583
Collaborator
(none)
1,000
Enrollment
12
Locations
38.3
Anticipated Duration (Months)
83.3
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Boston Scientific Ureteral Stents, Urinary Diversion Stent

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
Actual Study Start Date :
Feb 19, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Technical Success [2 months to 12 Months]

    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. Primary safety endpoint [2 months to 12 Months]

    Any Serious Adverse Device Effects

Secondary Outcome Measures

  1. Quality of Life - Patient-Reported Outcomes [2 months, 12 Months]

    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. Stent Migration [2 months to 12 Months]

    Stent Migration: Confirmed via imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Phoenix Phoenix Arizona United States 85054
2 University of Florida Shands Hospital Gainesville Florida United States 32608
3 Northwestern University-Department of Urology Chicago Illinois United States 60611
4 NorthShore University HealthSystem Glenview Illinois United States 60026
5 Indiana University Health Indianapolis Indiana United States 46202
6 University of Kansas Medical Center Kansas City Kansas United States 66160
7 HealthEast Medical Research Institute Saint Paul Minnesota United States 55102
8 New York Presbyterian Hospital-Columbia University Medical Center New York New York United States 10032
9 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
10 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
11 Centre Hospit Prive St Gregoire Vivalto St Gregoire France 35760
12 Nagoya City University Hospital Nagoya City Aichi Japan 467-8602

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT04197583
Other Study ID Numbers:
  • U0652
First Posted:
Dec 13, 2019
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Ureteral Obstruction

Study Results

No Results Posted as of Aug 24, 2022