Trial Outcomes & Findings for Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults (NCT NCT01439035)

Results Overview

OFDI images analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions. In this pilot study, we demonstrated the feasibility of using OFDI for visualizing changes of villous architecture in CD patients in vivo

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

during imaging session

Results posted on

2019-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	MGH OFDI Imaging OFDI imaging MGH OFDI Imaging: Imaging of Duodenum with OFDI system
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MGH OFDI Imaging n=6 Participants OFDI imaging MGH OFDI Imaging: Imaging of Duodenum with OFDI system
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	16.3 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: during imaging session

Population: Subjects 7 or over 7 years old with Celiac Disease

OFDI images analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions. In this pilot study, we demonstrated the feasibility of using OFDI for visualizing changes of villous architecture in CD patients in vivo

Outcome measures

Outcome measures
Measure	Compare OFDI Images to Histologic n=6 Participants compare OFDI images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease
Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging	6 Participants

Adverse Events

MGH OFDI 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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place