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

NeuroTherapia, Inc.

Status: Completed

Conditions: Esophageal Lesion

Treatments: Diagnostic Test: PillCam ESO Capsule Endoscope

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00990782

08-634

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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93 participants in 1 patient group

Single Arm

Experimental group

Description:

PillCam ESO Capsule Endoscope - all patients receive capsule endoscopy before and after RFA procedure.

Treatment:

Diagnostic Test: PillCam ESO Capsule Endoscope