Trial Outcomes & Findings for Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus (NCT NCT01439633)

Results Overview

Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

day 1, during diagnostic procedure

Results posted on

2019-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	MGH OFDI Marking and Imaging OFDI imaging MGH OFDI marking: Imaging of esophagus with OFDI system
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MGH OFDI Marking and Imaging n=22 Participants OFDI imaging MGH OFDI marking: Imaging of esophagus with OFDI system
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 11.84 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: day 1, during diagnostic procedure

Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.

Outcome measures

Outcome measures
Measure	MGH OFDI Marking and Imaging n=22 Participants OFDI imaging MGH OFDI marking: Imaging of esophagus with OFDI system
Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.	22 Participants

Adverse Events

MGH OFDI Marking and 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, 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