Removal of the Evolution® Esophageal Stent - Fully Covered
CLARITY
Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered
1 other identifier
interventional
130
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2018
CompletedResults Posted
Study results publicly available
February 23, 2022
CompletedSeptember 13, 2022
August 1, 2022
5.3 years
July 1, 2013
January 31, 2022
August 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Patients With Benign Indications That Achieved Clinical Success
7 days
Study Arms (1)
Evolution® Esophageal Stent
EXPERIMENTALInterventions
Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Harbor-University of California Los Angeles Medical Center
Torrance, California, 90502-2004, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Louisville, Division of Surgical Oncology
Louisville, Kentucky, 40202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Saunders, MDR, RAC; Manager, Biostatistics
- Organization
- Cook Research Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
John Vargo, M.D., M.P.H.
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2013
First Posted
July 16, 2013
Study Start
September 1, 2013
Primary Completion
December 10, 2018
Study Completion
December 10, 2018
Last Updated
September 13, 2022
Results First Posted
February 23, 2022
Record last verified: 2022-08