Double-J PLUS Postmarket Registry Study (NCT04197583) | Clinical Trial Compass
CompletedNot Applicable
Double-J PLUS Postmarket Registry Study
United States, Canada, France379 participantsStarted 2020-02-19
Plain-language summary
A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is a postmarket registry for the Double-J PLUS ureteral stent — can you explain what a ureteral stent does for ureter obstruction and whether this type of stent might be relevant to my specific situation?
2Since this trial tracked 'technical success' as a key outcome, what does technical success actually mean for a stent like this, and how would we know if it was working well enough in my case?
3The study is now completed — has any of its safety data been published yet, and can you walk me through what was found so we can weigh the risks together?
4Are there standard, well-established stenting options that have a longer track record compared to the Double-J PLUS, and how would you decide which is the better fit for me?
5Since this was a postmarket registry rather than a randomized controlled trial, how much does that affect how confident we can be in the safety and effectiveness findings when applying them to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Implanted Stents Meeting the Technical Success Criteria