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

This study has been completed.
Sponsor:
Collaborator:
Given Imaging Ltd.
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00990782
First received: October 6, 2009
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
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 Intervention
Esophageal Lesion Diagnostic Test: PillCam ESO Capsule Endoscope

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

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

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

Enrollment: 93
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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
  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: 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
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00990782     History of Changes
Other Study ID Numbers: 08-634
Study First Received: October 6, 2009
Results First Received: April 20, 2017
Last Updated: May 30, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on July 28, 2017