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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01900691
First received: July 1, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Esophageal Fistula
Esophageal Neoplasms
Esophageal Perforation
Esophageal Stenosis
Stents
Device: Evolution® Esophageal Stent - Fully Covered

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Successful removal of study stent [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical success [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Dysphagia [ Time Frame: 0 - 6 months ] [ Designated as safety issue: No ]
  • Incidence of procedural- and/or device-related adverse events [ Time Frame: 0 - 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of stent removal-related adverse events [ Time Frame: 30 days post-removal ] [ Designated as safety issue: Yes ]
  • Device integrity during the stent removal procedure [ Time Frame: At stent removal (up to 6 months) ] [ Designated as safety issue: Yes ]
  • Technical success [ Time Frame: at the end of the stent placement procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900691

Contacts
Contact: Maureen Timko 765-463-7537 mtimko@medinst.com

Locations
United States, California
Harbor-University of California Los Angeles Medical Center Recruiting
Torrance, California, United States, 90502-2004
Contact: Sofiya Reicher, MD    310-222-2475      
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Field Willingham, MD, MPH    404-778-3184    sarah.l.cristofaro@emory.edu   
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Neil Gupta, MD    708-216-2057    jrindels@lumc.edu   
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Shou Tang, MD    601-984-4540    stang@umc.edu   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Madhusudhan Sanaka, MD    216-444-3423    SANAKAM@ccf.org   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Cynthia Miller, RN    215-955-8108    Cynthia.miller@jefferson.edu   
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Bryan Sauer, MD    434-924-9582    bryansauer@virginia.edu   
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Kulwinder Dua, MD    414-995-6804    kdua@mcw.edu   
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: John Vargo, M.D., M.P.H. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01900691     History of Changes
Other Study ID Numbers: 11-012
Study First Received: July 1, 2013
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Esophageal Fistula
Esophageal Neoplasms
Esophageal Perforation
Esophageal Stenosis
Stents

Additional relevant MeSH terms:
Neoplasms
Constriction, Pathologic
Esophageal Fistula
Esophageal Neoplasms
Esophageal Perforation
Esophageal Stenosis
Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014