NCT01900691

Removal of the Evolution® Esophageal Stent - Fully Covered

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT01900691

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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.

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

Disease(s) and\or Condition(s)

Esophageal Fistula

Esophageal Neoplasms

Esophageal Perforation

Esophageal Stenosis

Stents

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DEVICE
- Name: Evolution® Esophageal Stent - Fully Covered
- Description: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
- Arm Group Labels: Evolution® Esophageal Stent

Sponsor

Cook Group Incorporated