Healthy
Conditions
Keywords
Healthy Volunteers
Brief summary
The purpose of this study is to test feasibility of a redesigned tethered capsule catheter that contains an integrated micro-motor. Investigators will be testing imaging of this new technology in healthy volunteers.
Detailed description
10 healthy volunteers will be enrolled and asked to swallow the Distal Scanning Capsule. The subjects will be awake and un-sedated. 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
DEVICEOFDI capsule
Imaging of esophagus using OFDI capsule and system
Sponsors
Massachusetts General Hospital
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 the inability to swallow pills and capsules. * Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule. * Subjects who have a bleeding disorder and are currently on anti-coagulants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule | Approximate 20 minute visit (5 min image acquisition) | An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed |
Countries
United States
Participant flow
Pre-assignment details
No significant events occurred after participants enrollment.
Participants by arm
| Arm | Count |
|---|---|
| OFDI Capsule Imaging Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | OFDI Capsule Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 24.5 years STANDARD_DEVIATION 5.06 |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule
An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed
Time frame: Approximate 20 minute visit (5 min image acquisition)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OFDI Capsule Imaging | Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule | 3 Participants |