ID-Cap System Under Direct Observation

NCT03475485 | Completed FDA Device

• 1 other identifier: ERX001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Ingestion event marker; Ingestible sensor; Medication adherence; ID-Cap Medication Adherence Feedback System

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Other Outcomes (3)

• Gender/BMI Effects

  Up to 10 Days

• Detection time

  Up to 60 minutes post ingestion

• Signal Duration

  Up to 90 minutes post ingestion

Study Arms (2)

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.

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

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.

Device: Wearable Sensor; Device: Placebo

Interventions

ID-Capsule- Active DEVICE

A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.

ID-Capsules- Active

Wearable Sensor DEVICE

Subjects will wear an ID-Reader

ID-Capsules- Active; ID-Capsules- Inactive

Placebo DEVICE

A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.

ID-Capsules- Inactive

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• EtectRX, Inc.: lead

Study Sites (1)

Quotient Sciences

Jacksonville, Florida, 32256, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gary Connor, RN

  EtectRX, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 23, 2018
• Study Start: March 22, 2018
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)