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

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

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 Overview

• Status: Completed
• Conditions: Esophageal Neoplasms; Stents; Esophageal Perforation; Esophageal Fistula; Esophageal Stenosis
• Intervention / Treatment: Device: Evolution® Esophageal Stent - Fully Covered

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
  • California
    • Torrance, California, United States, 90502-2004
      • Harbor-University of California Los Angeles Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, Division of Surgical Oncology
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evolution® Esophageal Stent	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cook Group Incorporated
• Investigators: Principal Investigator: John Vargo, M.D., M.P.H., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 10, 2018
• Study Completion (Actual): December 10, 2018

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 16, 2013

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: August 21, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Stents; Esophageal Fistula; Esophageal Neoplasms; Esophageal Perforation; Esophageal Stenosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Pathological Conditions, Anatomical; Esophageal Diseases; Digestive System Fistula; Fistula; Esophageal Neoplasms; Esophageal Perforation; Esophageal Stenosis; Esophageal Fistula
• Other Study ID Numbers: 11-012