Healthy Volunteers
Conditions
Keywords
Ingestion event marker, Ingestible sensor, Medication adherence, ID-Cap Medication Adherence Feedback System
Brief summary
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.
Interventions
DEVICEID-Capsule- Active
A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
DEVICEWearable Sensor
Subjects will wear an ID-Reader
DEVICEPlacebo
A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.
Sponsors
EtectRX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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. * Enroll at least one subject and less than four subjects 65 years of age or older * Enroll at least one subject and less than four subjects 18 to 21 years of age * 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
* Unable to take oral medications. * Women who are pregnant, breast-feeding, or plan to become pregnant during the study, and females of childbearing potential who are not using a medically-accepted means of contraception. * Medical condition which may affect passage through the gastrointestinal tract * Known hypersensitivity to any component of the ingestible ID-Capsule * Significant medical condition, psychiatric condition, current alcohol or drug abuse, or other condition which may preclude the study participant from being able to follow study procedures or to safely participate in the opinion of the investigator.. * Participation in an investigational product study (e.g., medical device or drug study) within 30 days prior to screening, or prior participation in an Ingestion Event Marker study. * Presence of an active implantable electronic medical device. * Positive screen for drugs of abuse (detection of drug for which a valid prescription exists is not exclusionary)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Detection Accuracy (PDA) | Up to 10 days | The number of active ingestible sensors detected divided by the number of active ingestible sensors administered under direct observation. |
| Negative Detection Accuracy (NDA) | Up to 10 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants with Adverse Events as a Measure of Safety and Tolerability | Up to 10 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion | Incidence of mild, moderate, and severe adverse events overall and related to the device; discontinuations due to adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gender/BMI Effects | Up to 10 Days | Effect of gender/BMI on the positive detection accuracy (covariate analysis) and other device performance measures |
| Detection time | Up to 60 minutes post ingestion | Time from ingestion of ID-Capsule to first detection by the ID-Cap Reader |
| Signal Duration | Up to 90 minutes post ingestion | Time from first to last detection of the signal from the ingested sensor by the ID-Cap Reader |
Countries
United States
Outcome results
None listed