Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment

NCT ID: NCT00990782

Last Updated: 2017-07-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Esophageal Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm

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

Group Type EXPERIMENTAL

PillCam ESO Capsule Endoscope

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Milan Dodig, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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08-634

Identifier Type: -

Identifier Source: org_study_id

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