Removal of the Evolution® Esophageal Stent - Fully Covered

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered

Conditions
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Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents

Intervention / Treatment
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* Device: Evolution® Esophageal Stent - Fully Covered


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evolution® Esophageal Stent<br> | Device: Evolution® Esophageal Stent - Fully Covered<br>* Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Successful Removal of Study Stent | The study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment. | 7 days to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Benign Indications That Achieved Clinical Success | The rate of clinical success in patients with strictures that showed improvement or relief of dysphagia symptoms or a seal sufficient to enable oral intake in patients with fistulas, perforations, or leaks. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents