A Study of the Removability of the Evolution® Esophageal Fully Covered Stent
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 15-007549
NCT ID: NCT01900691
Sponsor Protocol Number: 11-012
About this study
The purpose of this study is to evaluate the endoscopic removability of the Evolution® esophageal fully covered stent when used to treat patients with an obstruction caused by cancer or strictures, or for fistulas, perforations, or leaks.
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
- Patient is diagnosed with benign or malignant stricture, fistula, perforation, or leak
- Physician plans to remove the stent within the duration of study follow-up
Exclusion Criteria
- Patient is < 18 years of age
- Patient is unable or unwilling to provide written informed consent or comply with follow-up schedule
- Patient is pregnant, lactating, or planning on being pregnant within the next 6 months
- Patient is simultaneously participating in another investigational drug or device study
- Patient is contraindicated to upper GI endoscopy and/or any procedure to be performed in conjunction with esophageal stent placement
- Patient has a known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated
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 Francisco Ramirez, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available