Removal of the Evolution® Esophageal Stent - Fully Covered (CLARITY)

Cook Group

Status: Completed

Conditions: Esophageal Perforation; Esophageal Stenosis; Stents; Esophageal Neoplasms; Esophageal Fistula

Treatments: Device: Evolution® Esophageal Stent - Fully Covered

Study type: Interventional

Funder types: Industry

Identifiers

NCT01900691

11-012

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Evolution® Esophageal Stent

Experimental group

Treatment:

Device: Evolution® Esophageal Stent - Fully Covered