Trial Outcomes & Findings for OCT Pilot in Esophagus (NCT NCT03434834)

NCT ID: NCT03434834

Last Updated: 2021-04-06

Results Overview

Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: at baseline
• Results posted on: 2021-04-06

Participant Flow

Participant milestones

Measure	OCT of Esophagus All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
Overall Study STARTED	53
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	OCT of Esophagus All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
Overall Study unable to swallow OCT probe	16

Baseline Characteristics

OCT Pilot in Esophagus

Baseline characteristics by cohort

Measure	OCT of Esophagus n=53 Participants All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
Age, Continuous	66.3 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	53 Participants n=5 Participants
Stage of Barrett's Esophagus non-dysplastic Barrett's Esophagus	8 Participants n=5 Participants
Stage of Barrett's Esophagus Barrett's Esophagus with low grade dysplasia	24 Participants n=5 Participants
Stage of Barrett's Esophagus Barrett's Esophagus with high grade dysplasia	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: at baseline

Population: Participants who completed the study.

Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.

Outcome measures

Measure	OCT of Esophagus n=37 Participants All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa	93.1 percentage of imaged sites

PRIMARY outcome

Timeframe: at baseline

Population: Participants who completed the study.

Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.

Outcome measures

Measure	OCT of Esophagus n=37 Participants All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa	84.6 percentage of imaged sites

SECONDARY outcome

Timeframe: at baseline

Population: Participants who completed the study.

Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.

Outcome measures

Measure	OCT of Esophagus n=37 Participants All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image	80.5 percentage of imaged sites

Adverse Events

OCT of Esophagus

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	OCT of Esophagus n=53 participants at risk All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
Surgical and medical procedures sore throat	7.5% 4/53 • 1 week Subjects were contacted 1 week after OCT imaging to assess any adverse events.
Surgical and medical procedures bloating	1.9% 1/53 • 1 week Subjects were contacted 1 week after OCT imaging to assess any adverse events.
Surgical and medical procedures nausea / vomiting	1.9% 1/53 • 1 week Subjects were contacted 1 week after OCT imaging to assess any adverse events.
Surgical and medical procedures epigastric pain	1.9% 1/53 • 1 week Subjects were contacted 1 week after OCT imaging to assess any adverse events.
Surgical and medical procedures esophageal pain	1.9% 1/53 • 1 week Subjects were contacted 1 week after OCT imaging to assess any adverse events.

Additional Information

Dr. Adam Wax

Duke University

Phone: 919-660-5143

Email: a.wax@duke.edu

Results disclosure agreements

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