Back to resultsOFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OFDI Capsule
Sponsored by
About this trial
This is an interventional device feasibility trial for Atrial Fibrillation focused on measuring OFDI, RF Ablation, Atrial Fibrillation, Imaging, Esophagus
Eligibility Criteria
Inclusion Criteria:
- Subjects must be over 18 years of age
- Subjects must be able to give informed consent.
- Subjects must be referred to Massachusetts General Hospital (MGH) endoscopy for RF Ablation treatment of their Atrial Fibrillation.
Exclusion Criteria:
- Subjects with current esophageal strictures and dysphagia
- OR subjects with a prior history of intestinal strictures, prior GI surgery or intestinal Crohn's disease.
- OR subjects with a known history of chronic aspiration.
- OR women who are currently pregnant.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OFDI Capsule Imaging
Arm Description
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
Outcomes
Primary Outcome Measures
Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule
An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. A total of 6 subjects were enrolled in this study. 1 participant was not analyzed as they could not attempt to swallow the capsule.
Secondary Outcome Measures
Full Information
NCT ID
NCT02204566
First Posted
June 17, 2014
Last Updated
October 24, 2019
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02204566
Brief Title
OFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation
Official Title
Pilot Study of OFDI Capsule Imaging of the Esophagus of Patients With Atrial Fibrillation Following RF Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
12 patients with Atrial Fibrillation, a kind of irregular heart beat who have undergone Radio frequency (RF) ablation will be asked to swallow the capsule.
As they swallow the capsule, images of the esophagus will be taken to see if the RF ablation caused any form of damage to the esophagus considering it being so close to the heart.
After the capsule has been removed from the mouth, they will be asked about the tolerability of the capsule.
Detailed Description
A total of 12 patients with a known diagnosis of Atrial Fibrillation who have previously undergone Atrial RF ablation will be enrolled in the study. Patients will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.
As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
OFDI, RF Ablation, Atrial Fibrillation, Imaging, Esophagus
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OFDI Capsule Imaging
Arm Type
Experimental
Arm Description
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
Intervention Type
Device
Intervention Name(s)
OFDI Capsule
Intervention Description
Imaging of the esophagus using the OFDI Capsule and system
Primary Outcome Measure Information:
Title
Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule
Description
An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. A total of 6 subjects were enrolled in this study. 1 participant was not analyzed as they could not attempt to swallow the capsule.
Time Frame
After the completed imaging session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be over 18 years of age
Subjects must be able to give informed consent.
Subjects must be referred to Massachusetts General Hospital (MGH) endoscopy for RF Ablation treatment of their Atrial Fibrillation.
Exclusion Criteria:
Subjects with current esophageal strictures and dysphagia
OR subjects with a prior history of intestinal strictures, prior GI surgery or intestinal Crohn's disease.
OR subjects with a known history of chronic aspiration.
OR women who are currently pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Tearney, MD., PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
OFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation
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