Double-J PLUS Postmarket Registry

Boston Scientific

Status: Completed

Conditions: Ureter Obstruction

Treatments: Device: Boston Scientific Ureteral Stents, Urinary Diversion Stent

Study type: Observational

Funder types: Industry

Identifiers

NCT04197583

U0652

Details and patient eligibility

About

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

Enrollment: 379 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design