ID-Cap System Under Direct Observation

Clinical Performance of the ID-Cap System, an Ingestion Event Marker, in the Clinical Setting as an Aid to Measure Medication Adherence

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: ID-Capsule- Active; Device: Wearable Sensor; Device: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ID-Capsules- Active; 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.	Device: ID-Capsule- Active; A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.; Device: Wearable Sensor; Subjects will wear an ID-Reader
Placebo Comparator: ID-Capsules- Inactive; 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.	Device: Wearable Sensor; Subjects will wear an ID-Reader; Device: Placebo; A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: EtectRX, Inc.
• Investigators: Study Director: Gary Connor, RN, EtectRX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: March 18, 2018
• First Submitted That Met QC Criteria: March 18, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Medication adherence; Ingestion event marker; Ingestible sensor; ID-Cap Medication Adherence Feedback System
• Other Study ID Numbers: ERX001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No