Removal of the Evolution® Esophageal Stent - Fully Covered (NCT01900691) | Clinical Trial Compass
CompletedNot Applicable
Removal of the Evolution® Esophageal Stent - Fully Covered
United States130 participantsStarted 2013-09
Plain-language 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.
Who can participate
Age range
18 Years
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:
* 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
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Number of Patients With Successful Removal of Study Stent