N/A
N=379
Double-J PLUS Postmarket Registry Study
Ureter Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT04197583 ↗Enrolled (actual)
379
Serious AEs
3.9%
Results posted
Oct 2024
Primary outcome: Primary: Percentage of Implanted Stents Meeting the Technical Success Criteria — 242; 158; 4; 2 Stent Implanted
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Boston Scientific Ureteral Stents, Urinary Diversion Stent (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Implanted Stents Meeting the Technical Success Criteria |
242; 158; 4; 2 | — |
| PRIMARY Primary Safety Endpoint |
2; 3; 213; 141 | — |
| SECONDARY Quality of Life - Patient-Reported Outcomes |
-1.83; 2.04; -9.51; -10.79; -2.76; 2.25 | — |
| SECONDARY Stent Migration |
3; 2; 260; 163 | — |
Summary
A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04197583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.