Trial Outcomes & Findings for Study to Image the Esophagus Using the OFDI Capsule (NCT NCT02204150)

NCT ID: NCT02204150

Last Updated: 2019-04-30

Results Overview

Number of subjects from whom the quality OFDI imaging was obtained

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
• Results posted on: 2019-04-30

Participant Flow

In this feasibility study we try to establish the overall number of participants who are able to swallow the capsule and provide us with quality imaging using this new technology. At this point we do no distinguish tolerability separately in each of the three groups and are treating them as one.

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	56
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Image the Esophagus Using the OFDI Capsule

Baseline characteristics by cohort

Measure	OFDI Capsule Imaging n=56 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	50 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	38 Participants n=93 Participants
Region of Enrollment United States	56 Participants n=93 Participants

PRIMARY outcome

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

Number of subjects from whom the quality OFDI imaging was obtained

Outcome measures

Measure	OFDI Capsule Imaging n=56 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
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule	56 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

Gary Tearney

Mass General Hospital

Phone: 617-724-2979

Email: gtearney@partners.org

Results disclosure agreements

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