The ID-Cap System is classified as an ingestion event marker (IEM), a Class II medical device. The system is intended to record time-stamped ingestions with the ingestible sensor, ID-Tag which transmits a signal to a wearable device, the ID-Cap Reader. In this study, 36 subjects will ingest capsules containing ingestible sensors while wearing the Reader and being observed in a clinic setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
TRIPLE
Enrollment
36
A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
Subjects will wear an ID-Reader
A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.
Quotient Sciences
Jacksonville, Florida, United States
Positive Detection Accuracy (PDA)
The number of active ingestible sensors detected divided by the number of active ingestible sensors administered under direct observation.
Time frame: Up to 10 days
Negative Detection Accuracy (NDA)
The number of inactive empty capsules not detected divided by the number of inactive empty capsules administered under direct observation. Determination of NDA will also include the number of monitoring periods with no ingestion events detected by the Reader divided by the number of specific monitoring periods performed for the purpose of detecting false positives.
Time frame: Up to 10 days
Number of Study Participants with Adverse Events as a Measure of Safety and Tolerability
Incidence of mild, moderate, and severe adverse events overall and related to the device; discontinuations due to adverse events
Time frame: Up to 10 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.