Removal of the Evolution® Esophageal Stent - Fully Covered

Not Applicable

Completed

Conditions: Esophageal Neoplasms
Esophageal Fistula
Esophageal Perforation
Stents
Esophageal Stenosis

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Evolution® Esophageal Stent	Evolution® Esophageal Stent - Fully Covered	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Successful Removal of Study Stent	7 days to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Benign Indications That Achieved Clinical Success	7 days	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.

Locations (11): Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Harbor-University of California Los Angeles Medical Center
🇺🇸
Torrance, California, United States
University of Virginia Health System
🇺🇸
Charlottesville, Virginia, United States
Mayo Clinic
🇺🇸
Phoenix, Arizona, United States
University of Louisville, Division of Surgical Oncology
🇺🇸
Louisville, Kentucky, United States
Froedtert Hospital
🇺🇸
Milwaukee, Wisconsin, United States
Methodist Dallas Medical Center
🇺🇸
Dallas, Texas, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States