Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment

Esophageal Lesion Clinical Trial

— CEPELA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990782
• Other study ID #: 08-634
• Status: Completed
• Phase: N/A
• First received: October 6, 2009
• Last updated: March 21, 2017
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: March 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Lesion

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Given Imaging Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	capability of the PillCam ESO 2 capsule endoscope to identify esophageal injury due to RFA therapy for atrial fibrillation		24-48 hrs post RFA, and 14 days post-RFA
Secondary	compare patient post-ablation symptoms to esophageal injury findings identified by PillCam ESO capsule endoscope		24-48 hrs post-RFA and 14 days post-RFA