Double-J PLUS Postmarket Registry

Ureter Obstruction Clinical Trial

Official title:

Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197583
• Other study ID #: U0652
• Status: Completed
• Start date: February 19, 2020
• Est. completion date: February 22, 2023

Study information

• Verified date: July 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: February 22, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ureter Obstruction
• Ureteral Obstruction

Intervention

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.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia
France	Centre Hospit Prive St Gregoire Vivalto	St Gregoire
Japan	Nagoya City University Hospital	Nagoya City	Aichi
United States	Northwestern University-Department of Urology	Chicago	Illinois
United States	NorthShore University HealthSystem	Glenview	Illinois
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	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	Mayo Clinic Phoenix	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada,  France,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Primary safety endpoint	Any Serious Adverse Device Effects	2 months to 12 Months
Secondary	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
Secondary	Stent Migration	Stent Migration: Confirmed via imaging	2 months to 12 Months