Removal of the Evolution® Esophageal Stent - Fully Covered

Esophageal Neoplasms Clinical Trial

— CLARITY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900691
• Other study ID #: 11-012
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 10, 2018

Study information

• Verified date: August 2022
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Esophageal Fistula
• Esophageal Neoplasms
• Esophageal Perforation
• Esophageal Stenosis
• Fistula
• Stents

Intervention

Device:
• Evolution® Esophageal Stent - Fully Covered
Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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