Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment

Not Applicable

Completed

• Conditions: Esophageal Lesion
• Interventions: Diagnostic Test: PillCam ESO Capsule Endoscope

• Registration Number: NCT00990782
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Primary Completion: 2010-06
• Study Completion: 2010-09
• Results First Submitted: 2017-04-20
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-05-30
• Results First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	PillCam ESO Capsule Endoscope	PillCam ESO Capsule Endoscope - all patients receive capsule endoscopy before and after RFA procedure.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy	14 days

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA	14 Days

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States