Double-J PLUS Postmarket Registry Study

NCT04197583 | Completed Results FDA Device

• 1 other identifier: U0652
• Study Type: observational
• Target: 379
• Locations: 4 countries
• Sites: 10

Brief Summary

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

Conditions

Ureter Obstruction

Outcome Measures

Primary Outcomes (2)

• 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.

  2 months to 15 Months

• Primary Safety Endpoint

  Any Serious Adverse Device Effects

  2 months to 15 Months

Secondary Outcomes (2)

• Quality of Life - Patient-Reported Outcomes

  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

  2 months to 15 Months

Interventions

Boston Scientific Ureteral Stents, Urinary Diversion Stent DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study will enroll patients who are receiving a Boston Scientific Ureteral stent or Urinary Diversion Stent as part of their standard of care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (10)

Mayo Clinic Phoenix

Phoenix, Arizona, 85054, United States

Location

Northwestern University-Department of Urology

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem

Glenview, Illinois, 60026, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, 10032, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Centre Hospit Prive St Gregoire Vivalto

Saint-Grégoire, 35760, France

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Boston Scientific

teresa.takle-flach@bsci.com

5133058628

Study Officials

• Amy Krambeck

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Michael Borofsky

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: February 19, 2020
• Primary Completion: January 16, 2023
• Study Completion: February 22, 2023
• Last Updated: March 3, 2026
• Results First Posted: October 16, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); JP (1); FR (1); CA (1)