A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents
Study Type
OBSERVATIONAL
Enrollment
379
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.
Mayo Clinic Phoenix
Phoenix, Arizona, United States
Northwestern University-Department of Urology
Chicago, Illinois, United States
NorthShore University HealthSystem
Glenview, Illinois, United States
Percentage of Implanted Stents Meeting the Technical Success Criteria
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.
Time frame: 2 months to 15 Months
Primary Safety Endpoint
Any Serious Adverse Device Effects
Time frame: 2 months to 15 Months
Quality of Life - Patient-Reported Outcomes
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
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
Stent Migration
Stent Migration: Confirmed via imaging
Time frame: 2 months to 15 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indiana University Health
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
Centre Hospit Prive St Gregoire Vivalto
Saint-Grégoire, France
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan