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Completed

NCT Number: NCT00990782

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.

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Key information

Conditions

Esophageal Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PillCam ESO Capsule Endoscope

Diagnostic Test

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 outcomes

  1. Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy

    Time frame: 14 days

Secondary outcomes

  1. Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA

    Time frame: 14 Days

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

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

Acronym: CEPELA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 7, 2009
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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