Barrett's Esophagus, Eosinophilic Esophagitis
Conditions
Keywords
Optical Coherence Tomography, Barrett's Esophagus, Esophagus, Imaging
Brief summary
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
Detailed description
A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done. As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
Interventions
DEVICEOFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A previous diagnosis of Barrett's Esophagus * OR a previous diagnosis of EoE * OR a previous diagnosis of Gastroesophageal reflux disease (GERD) * Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE * Subject must be able to give informed consent
Exclusion criteria
* Subjects with known esophageal strictures, intestinal strictures or dysphagia * OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule | Images will be acquired during the OFDI imaging session which should take an average of 5 minutes | Number of subjects from whom the quality OFDI imaging was obtained |
Countries
United States
Participant flow
Pre-assignment details
In this feasibility study we try to establish the overall number of participants who are able to swallow the capsule and provide us with quality imaging using this new technology. At this point we do no distinguish tolerability separately in each of the three groups and are treating them as one.
Participants by arm
| Arm | Count |
|---|---|
| OFDI Capsule Imaging Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | OFDI Capsule Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Region of Enrollment United States | 56 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 56 |
| other Total, other adverse events | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 |
Outcome results
Primary
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
Number of subjects from whom the quality OFDI imaging was obtained
Time frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OFDI Capsule Imaging | Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule | 56 Participants |