Removal of the Evolution® Esophageal Stent - Fully Covered

N/ACompletedNCT01900691

Cook Group Incorporated130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Esophageal Fistula Esophageal Neoplasms Esophageal Perforation Esophageal Stenosis Stents

Interventions

Evolution® Esophageal Stent - Fully CoveredDEVICE

Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Mayo Clinic

Phoenix, Arizona, United States

Harbor-University of California Los Angeles Medical Center

Torrance, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 7 days to 6 months

Secondary Outcomes

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.

Time frame: 7 days

Data from ClinicalTrials.gov

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