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

Primary Purpose

Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Evolution® Esophageal Stent - Fully Covered
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Fistula focused on measuring Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic
  • Harbor-University of California Los Angeles Medical Center
  • Emory University Hospital
  • Loyola University Medical Center
  • University of Louisville, Division of Surgical Oncology
  • University of Mississippi Medical Center
  • Cleveland Clinic
  • Thomas Jefferson University
  • Methodist Dallas Medical Center
  • University of Virginia Health System
  • Froedtert Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evolution® Esophageal Stent

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 1, 2013
Last Updated
August 21, 2022
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01900691
Brief Title
Removal of the Evolution® Esophageal Stent - Fully Covered
Acronym
CLARITY
Official Title
Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents
Keywords
Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evolution® Esophageal Stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Evolution® Esophageal Stent - Fully Covered
Intervention Description
Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
Primary Outcome Measure Information:
Title
Number of Patients With Successful Removal of Study Stent
Description
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 Outcome Measure Information:
Title
Number of Patients With Benign Indications That Achieved Clinical Success
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Vargo, M.D., M.P.H.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Harbor-University of California Los Angeles Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502-2004
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Louisville, Division of Surgical Oncology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Removal of the Evolution® Esophageal Stent - Fully Covered

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