Trial Outcomes & Findings for Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction (NCT NCT01401699)

Results Overview

Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

Images will be acquired during the OFDI imaging session which should take an average of 5 minutes

Results posted on

2023-01-18

Participant milestones
Measure	Optical Frequency Domain Imaging System OFDI imaging Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus
Overall Study STARTED	109
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction

Baseline characteristics by cohort
Measure	Optical Frequency Domain Imaging System n=109 Participants OFDI imaging Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants
Region of Enrollment United States	109 Participants n=5 Participants

Timeframe: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes

Population: All subjects completed the study with no adverse events.

Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.

Outcome measures
Measure	Optical Frequency Domain Imaging n=109 Participants Optical Frequency Domain imaging data
Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening	109 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Optical Frequency Domain Imaging System n=109 participants at risk OFDI imaging Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus
Investigations aspiration	0.00% 0/109 • During the imaging session

Massachusetts General Hospital

Phone: 617-724-2979