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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, 12-18 subjects will ingest capsules containing ingestible sensors while wearing the Reader and being observed in a clinic setting.
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Enrollment will be stratified to include at least two study participants in each BMI-Gender category. The BMI-Gender categories will be: Normal/Underweight (BMI<25), Overweight (BMI 25.0 to <30), and Obese (BMI>30.0); and Male/Female.
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13 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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