Double-J PLUS Postmarket Registry

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

Official Title
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Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry

Conditions
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Ureter Obstruction

Intervention / Treatment
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* Device: Boston Scientific Ureteral Stents, Urinary Diversion Stent


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | 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 months to 12 Months | 
| Primary safety endpoint | Any Serious Adverse Device Effects | 2 months to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - Patient-Reported Outcomes | 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 months, 12 Months | 
| Stent Migration | Stent Migration: Confirmed via imaging | 2 months to 12 Months |