Double-J PLUS Ureteral Stent Patient Registry
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 20-001307
NCT ID: NCT04197583
About this study
The purpose of this study is to obtain postmarket safety and efficacy data on Boston Scientific Double-J Ureteral Stents.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject is undergoing placement of a Boston Scientific Double-J 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) and return for all follow-up visits.
Exclusion Criteria:
- Subjects who meet any of the contraindications per individual stent directions for use (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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Mitchell Humphreys, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available