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| Name | Class |
|---|---|
| Quotient Sciences | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ID-Capsules- Active | Experimental | Subjects will ingest ID-Capsules containing the ingestible sensor which emits a signal from within the subject's stomach. This signal is detected by the wearable Reader, and the ingestion event is recorded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID-Capsule- Active | Device | A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive Detection Accuracy (PDA) | The number of active ingestible sensors detected divided by the number of active ingestible sensors administered under direct observation. | Up to 6 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. | Up to 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion] |
| Measure | Description | Time Frame |
|---|---|---|
| Detection Time | Time from ingestion of ID-Capsule to first detection by the ID-Cap Reader | Up to 60 minutes post ingestion |
| Signal Duration | Time from first to last detection of the signal from the ingested sensor by the ID-Cap Reader |
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.
Inclusion Criteria:
Exclusion Criteria:
Gender at birth
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| Name | Affiliation | Role |
|---|---|---|
| Gary Connor, RN | EtectRX, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Miami | Florida | 33126 | United States |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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This study is a prospective, open label, clinical study evaluating the safety and effectiveness of the ID-Cap System under direct observation in the clinical setting.
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| Wearable Sensor | Device | Subjects will wear an ID-Reader |
|
| Up to 60 minutes post ingestion |
| D001519 | Behavior |