Double-J PLUS Postmarket Registry

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

379 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-19

Study Completion Date

2023-02-22

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

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Detailed Description

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Conditions

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Ureter Obstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No