Healthy
Conditions
Keywords
Primary Care, Healthy
Brief summary
The goal of this study is to test the feasibility and acceptability of tethered capsule Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening in the primary care practice environment.
Detailed description
60 healthy volunteers scheduled for a routine primary care visit will be recruited and asked to swallow the OCT capsule while being awake and unsedated. The capsule is attached to a 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 and later analyzed.
Interventions
DEVICEMGH OCT Imaging Capsule
Imaging of the esophagus using the OCT Capsule and system.
Sponsors
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 scheduled for non-urgent appointment at primary care practice including annual wellness visits and routine follow-up appointments. * Subjects must be over the age of 18 * Subjects must be able to give informed consent * Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
Exclusion criteria
* Subjects with current symptoms of dysphagia * Subjects with any history of intestinal strictures, prior GI surgery, or history of intestinal Crohn's disease. * Subjects with current symptoms of fever, nausea or sore throat at the time of the appointment. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting. | Approximate 20min visit (5min image acquisition) | Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis. |
Countries
United States
Participant flow
Recruitment details
A total number of 60 Participants were enrolled in the study
Participants by arm
| Arm | Count |
|---|---|
| Feasibility Number of participants able to swallow the capsule and capture OCT images successfully. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Feasibility |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 46 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting.
Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis.
Time frame: Approximate 20min visit (5min image acquisition)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Feasibility | Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting. | 45 Participants |