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

CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment

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 Overview

• Status: Completed
• Conditions: Esophageal Lesion
• Intervention / Treatment: 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
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA	14 Days

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Medtronic - MITG
• Investigators: Principal Investigator: Milan Dodig, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: October 6, 2009
• First Submitted That Met QC Criteria: October 6, 2009
• First Posted (Estimate): October 7, 2009

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 08-634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No