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Trial Outcomes & Findings for OFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation (NCT NCT02204566)

NCT ID: NCT02204566

Last Updated: 2019-11-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

After the completed imaging session

Results posted on

2019-11-08

Participant Flow

Participant milestones

Participant milestones
Measure
OFDI Capsule Imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system
Overall Study
STARTED
5
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
OFDI Capsule Imaging
n=5 Participants
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=93 Participants
Age, Categorical
>=65 years
2 Participants
n=93 Participants
Age, Continuous
62 years
STANDARD_DEVIATION 7 • n=93 Participants
Sex: Female, Male
Female
3 Participants
n=93 Participants
Sex: Female, Male
Male
2 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Region of Enrollment
United States
5 Participants
n=93 Participants

PRIMARY outcome

Timeframe: After the completed imaging session

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.

Outcome measures

Outcome measures
Measure
Feasibility
n=5 Participants
Number of Participants with Acceptable Quality of Images Who Swallow the OFDI Capsule
Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule
1 Participants

Adverse Events

OFDI Capsule Imaging

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gary Tearney, PI

Massachusetts General Hospital

Phone: 617-724-2979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place