ID-Cap System Under Direct Observation

EtectRX

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: Placebo; Device: Wearable Sensor; Device: ID-Capsule- Active

Study type: Interventional

Funder types: Industry

Identifiers

NCT03475485

ERX001

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

ID-Capsules- Active

Experimental group

Description:

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.

Treatment:

Device: ID-Capsule- Active

Device: Wearable Sensor

ID-Capsules- Inactive

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo

Device: Wearable Sensor