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Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment (CEPELA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00990782
Recruitment Status : Completed
First Posted : October 7, 2009
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Given Imaging Ltd.
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.

Condition or disease Intervention/treatment
Esophageal Lesion Diagnostic Test: PillCam ESO Capsule Endoscope

Detailed Description:
Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatment area. This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
Study Start Date : September 2009
Primary Completion Date : June 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Arm
PillCam ESO Capsule Endoscope - all patients receive capsule endoscopy before and after RFA procedure.
Diagnostic Test: PillCam ESO Capsule Endoscope
Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.



Primary Outcome Measures :
  1. Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA [ Time Frame: 14 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation
  • Adults aged 18 years and older
  • Patients able to give informed consent

Exclusion Criteria:

  • Patients under the age of 18
  • Patient unable to or unwilling to swallow the capsule endoscopes
  • Patients with cardiac pacemakers, implanted cardiac defibrillators or other implanted electro-medical devices
  • Pregnant or lactating females
  • Subjects with history of abdominal, pelvic, or bowel surgery within the past year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990782


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Given Imaging Ltd.
Investigators
Principal Investigator: Milan Dodig, MD The Cleveland Clinic

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00990782     History of Changes
Other Study ID Numbers: 08-634
First Posted: October 7, 2009    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No