Double-J PLUS Postmarket Registry

• ClinicalTrials.gov Identifier: NCT04197583
• Recruitment Status: Completed
• First Posted: December 13, 2019
• Last Update Posted: May 16, 2023
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Tracking Information

• First Submitted Date: December 11, 2019
• First Posted Date: December 13, 2019
• Last Update Posted Date: May 16, 2023
• Actual Study Start Date: February 19, 2020
• Actual Primary Completion Date: January 16, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 12, 2021)

• Technical Success [ Time Frame: 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.
• Primary safety endpoint [ Time Frame: 2 months to 12 Months ]
  Any Serious Adverse Device Effects

Original Primary Outcome Measures (submitted: December 11, 2019)

• Technical Success [ Time Frame: 2 months to 12 Months ]
  Stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters
• Primary safety endpoint [ Time Frame: 2 months to 12 Months ]
  Any Serious Adverse Device Effects

Current Secondary Outcome Measures (submitted: December 11, 2019)

• Quality of Life - Patient-Reported Outcomes [ Time Frame: 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
• Stent Migration [ Time Frame: 2 months to 12 Months ]
  Stent Migration: Confirmed via imaging

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Double-J PLUS Postmarket Registry
• Official Title: Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
• 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 Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 15 Months
• Biospecimen: Not Provided
• 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.
• Condition: Ureter Obstruction

Intervention

Device: Boston Scientific Ureteral Stents, Urinary Diversion Stent

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.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 10, 2022): 379
• Original Estimated Enrollment (submitted: December 11, 2019): 600
• Actual Study Completion Date: February 22, 2023
• Actual Primary Completion Date: January 16, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, France, Japan, United States

Administrative Information

• NCT Number: NCT04197583
• Other Study ID Numbers: U0652
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Boston Scientific Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: Boston Scientific Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Boston Scientific Corporation
• Verification Date: May 2023