N/A
N=130
Removal of the Evolution® Esophageal Stent - Fully Covered
Esophageal Fistula · Esophageal Neoplasms · Esophageal Perforation · Esophageal Stenosis · Stents
Bottom Line
View on ClinicalTrials.gov: NCT01900691 ↗Enrolled (actual)
130
Serious AEs
35.4%
Results posted
Feb 2022
Primary outcome: Primary: Number of Patients With Successful Removal of Study Stent — 57 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Evolution® Esophageal Stent - Fully Covered (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Group Incorporated
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Successful Removal of Study Stent |
57 | — |
| SECONDARY Number of Patients With Benign Indications That Achieved Clinical Success |
44 | — |
Summary
The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.
Eligibility Criteria
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 that 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
Data sourced from ClinicalTrials.gov (NCT01900691). 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.