Clinical trial NCT04197583: Double-J PLUS Postmarket Registry
Official title: Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureter Obstruction
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 379
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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

Primary outcomes:
measure: Percentage of Implanted Stents Meeting the Technical Success Criteria
timeFrame: 2 months to 15 Months
measure: Primary Safety Endpoint
timeFrame: 2 months to 15 Months
Secondary outcomes:
measure: Quality of Life - Patient-Reported Outcomes
timeFrame: 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
measure: Stent Migration
timeFrame: 2 months to 15 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Phoenix
state: Arizona
city: Chicago
country: United States
facility: Northwestern University-Department of Urology
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New York
country: United States
facility: New York Presbyterian Hospital-Columbia University Medical Center
state: New York
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: St Gregoire
country: France
facility: Centre Hospit Prive St Gregoire Vivalto
city: Nagoya City
country: Japan
facility: Nagoya City University Hospital
state: Aichi
Study officials:
affiliation: Northwestern University
name: Amy Krambeck
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Michael Borofsky
role: PRINCIPAL_INVESTIGATOR
References: