Barrett's Esophagus, Gastric Acid Reflux, Healthy
Conditions
Keywords
Barrett's, GERD, Capsule, SECM
Brief summary
The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).
Detailed description
36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated. The capsule is attached to a string like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis. As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.
Interventions
DEVICEMGH SECM Imaging Capsule
Imaging of the Esophagus using the SECM capsule and SECM Imaging system
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older). * AND Subject must be able to give informed consent. * AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.
Exclusion criteria
* Subjects with any history of or known upper gastrointestinal strictures * OR Subjects with a history of Crohn's disease, * OR Subjects with difficulty swallow
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule. | 20 minute visit (5-7 minute imaging) | The number of subjects from whom successful SECM imaging was obtained |
Countries
United States
Participant flow
Pre-assignment details
In this study we were trying to establish how many participants can provide us with quality imaging using this new technology. Therefore we treated them as one group. 2 healthy subjects and one with BE were enrolled. Upon reviewing imaging data it was concluded that this new technology is not optimal for the study and the enrollment was stopped.
Participants by arm
| Arm | Count |
|---|---|
| MGH SECM Imaging Capsule Subject will swallow the new large SECM imaging capsule and images will be acquired using the SECM Imaging system. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | MGH SECM Imaging Capsule |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
The number of subjects from whom successful SECM imaging was obtained
Time frame: 20 minute visit (5-7 minute imaging)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MGH SECM Imaging Capsule | Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule. | 3 Participants |