Trial Outcomes & Findings for Optical Frequency Domain Imaging for Assessing Colonic Polyps (NCT NCT01439087)

Last Updated: 2023-07-27

Results Overview

OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated.

Recruitment status

COMPLETED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

During the OFDI imaging session which should take an average of 5 mintues

Results posted on

2023-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	OFDI Imaging OFDI imaging MGH Optical Frequency Domain Imaging (OFDI) System: Imaging of Colonic Polyps with OFDI system
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optical Frequency Domain Imaging for Assessing Colonic Polyps

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OFDI Imaging n=2 Participants OFDI imaging MGH Optical Frequency Domain Imaging (OFDI) System: Imaging of Colonic Polyps with OFDI system
Age, Categorical <=18 years	0 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
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the OFDI imaging session which should take an average of 5 mintues

Outcome measures

Outcome measures
Measure	Feasibility & Sensitivity of OFDI Imaging in the Colon n=2 Participants Feasibility is measured by the number of enrolled subjects that met imaging eligibility criteria and were successfully imaged with the OFDI device. Sensitivity is measured by the number of enrolled subjects that met eligibility criteria, and had a polyp(s) successfully imaged and identified by the OFDI device.
Feasibility and Sensitivity of OFDI Imaging in the Colon Sensitivity	1 Participants
Feasibility and Sensitivity of OFDI Imaging in the Colon Feasibility	2 Participants

Adverse Events

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

Gary Tearney, MD, PhD

Massachusetts General Hospital

Phone: 617-724-2979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place