Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ID-Capsules- Active | Experimental | Randomly-assigned ingestions of ID-Capsules containing ingestible sensors (ID-Capsule- Active) while wearing the ID-Cap Reader (Wearable Sensor) under direct observation • 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. |
|
| ID-Capsules- Inactive | Placebo Comparator | Randomly-assigned ingestions of ID-Capsules containing no ingestible sensors while wearing the ID-Cap Reader under direct observation • Subjects will also ingest empty placebo capsules that do not contain ingestible sensors. In the absence of an ingested sensor, no signal is received by the Reader after the capsule is ingested, and the ingestion event is not 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 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. | Up to 10 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 10 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Gender/BMI Effects | Effect of gender/BMI on the positive detection accuracy (covariate analysis) and other device performance measures | Up to 10 Days |
| Detection time | Time from ingestion of ID-Capsule to first detection by the ID-Cap Reader |
Stratification for gender and Body Mass Index is performed.
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:
Men and women 18 years of age or older.
For females of childbearing potential, negative urine pregnancy test at time of entry and assurance that a medically-accepted means of contraception will be used for the duration of the study. Able and willing to provide informed consent.
Willing to adhere to all protocol requirements and study procedures.
Adequate organ function at screening (defined for investigator in protocol)
Exclusion Criteria:
Gender at birth
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gary Connor, RN | EtectRX, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Jacksonville | Florida | 32256 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
This study is a prospective, blinded, clinical study evaluating the safety and effectiveness of the ID-Cap System under direct observation in the clinical setting. Subjects will ingest a series of active ID capsules containing ingestible sensors and a series of empty placebo capsules that will be randomly administered. The ID-Capsule System's feasibility/ability to properly record actual ingestions (Positive Detection Accuracy) and to not record blank ingestions (Negative Detection Accuracy) will be evaluated.
Not provided
Not provided
Capsules are identical in appearance. Only unblinded pharmacy personnel at the study site will be aware of the ingestion allocation of active ID-Capsules or placebo capsules.
| Wearable Sensor | Device | Subjects will wear an ID-Reader |
|
| Placebo | Device | A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor. |
|
| 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 | Up to 90 minutes post ingestion |
| D001519 | Behavior |