Ureter ObstructionNCT04197583
Double-J PLUS Postmarket Registry Study
An observational study of Ureter Obstruction, run by Boston Scientific Corporation at 10 sites in 4 countries.
Trial summary
A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ureter Obstruction
- What is being tested?
- Boston Scientific Ureteral Stents, Urinary Diversion Stent
- Type of treatment
- Medical device
- How many people
- 379 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 19 Feb 2020to 22 Feb 2023
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States7 sites
Northwestern University-Department of Urology
Chicago, Illinois, 60611
NorthShore University HealthSystem
Glenview, Illinois, 60026
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Indiana University Health
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
About this study
Official title: Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents
Read the detailed description
A multi-center registry study to obtain post-market clinical data on safety and effectiveness of the Boston Scientific Ureteral and Urinary Diversion Stents
- Conditions
- Ureter Obstruction
- Being tested
- Boston Scientific Ureteral Stents, Urinary Diversion Stent
- Medical subject headings
- Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Ureteral Stents, Urinary Diversion StentDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months to 15 Months
Primary Safety Endpoint
Any Serious Adverse Device Effects
Measured: 2 months to 15 Months
Secondary outcomes (2)
Quality of Life - Patient-Reported Outcomes
Measurement System Patient Reported Outcomes Measurement Information System (PROMIS®) for subjects ≥18 years
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity 3a, score range for the change from Index procedure is -41.1 to 41.1
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference 6b, score range for the change from Index procedure is -37.3 to 37.3
Higher PROMIS score means worse quality of life
Measured: 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
Stent Migration: Confirmed via imaging
Measured: 2 months to 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start19 Feb 2020
- Primary completion16 Jan 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ureter ObstructionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Krambeck, Principal investigator, Northwestern UniversityMichael Borofsky, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197583
- Sponsor's protocol ID
- U0652
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2019
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
- ClinicalTrials.gov ID
- NCT04197583
- Acronym / sponsor ID
- U0652
- Conditions
- Ureter Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents
Detailed description
A multi-center registry study to obtain post-market clinical data on safety and effectiveness of the Boston Scientific Ureteral and Urinary Diversion Stents
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
- Subjects who meet any of the contraindications per individual stent DFU
- Subjects receiving different stent type in case of bilateral/multiple stenting
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boston Scientific Ureteral Stents, Urinary Diversion StentA 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. | Device | – |
Primary outcome
Percentage of Implanted Stents Meeting the Technical Success Criteria
Time frame: 2 months to 15 Months
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.
Primary Safety Endpoint
Time frame: 2 months to 15 Months
Any Serious Adverse Device Effects
2 secondary outcomes
Quality of Life - Patient-Reported Outcomes
Time frame: 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
Time frame: 2 months to 15 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Krambeck principal investigator
Northwestern University
Michael Borofsky principal investigator
University of Minnesota
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureter Obstruction, run by Boston Scientific Corporation at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, France, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Implanted Stents Meeting the Technical Success Criteria (time frame: 2 months to 15 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.