Trial Outcomes & Findings for Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe (NCT NCT02210039)

Last Updated: 2019-04-03

Results Overview

We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

During the procedure

Results posted on

2019-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	SECM Probe Imaging SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. SECM Probe: Imaging of the esophagus using SECM probe and system.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SECM Probe Imaging n=6 Participants SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. SECM Probe: Imaging of the esophagus using SECM probe and system.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	65.16 years STANDARD_DEVIATION 12.20 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	6 participants n=99 Participants

PRIMARY outcome

Timeframe: During the procedure

Population: All six study participants completed the study and the obtained data has been analyzed

Outcome measures

Outcome measures
Measure	SECM Probe Imaging n=6 Participants SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. SECM Probe: Imaging of the esophagus using SECM probe and system.
Number of Participants With Tolerability of the Procedure	6 Participants

Adverse Events

SECM Probe 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

Guillermo 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