Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
CEPELA
CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
1 other identifier
interventional
93
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 6, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
July 2, 2017
CompletedJuly 2, 2017
May 1, 2017
9 months
October 6, 2009
April 20, 2017
May 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy
14 days
Secondary Outcomes (1)
Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA
14 Days
Study Arms (1)
Single Arm
EXPERIMENTALPillCam ESO Capsule Endoscope - all patients receive capsule endoscopy before and after RFA procedure.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation
- Adults aged 18 years and older
- Patients able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Cleveland Cliniclead
- Medtronic - MITGcollaborator
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Results Point of Contact
- Title
- Dr. John Vargo
- Organization
- Cleveland Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Milan Dodig, MD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2009
First Posted
October 7, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2010
Study Completion
September 1, 2010
Last Updated
July 2, 2017
Results First Posted
July 2, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share