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

NCT03653897 | Completed FDA Device

• 1 other identifier: ERX002
• Study Type: interventional
• Target: 13
• 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, 12-18 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 6 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 6 days

Secondary Outcomes (1)

• Number of Study Participants with Adverse Events as a Measure of Safety and Tolerability

  Up to 6 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion]

Other Outcomes (2)

• Detection Time

  Up to 60 minutes post ingestion

• Signal Duration

  Up to 60 minutes post ingestion

Study Arms (1)

ID-Capsules- Active

EXPERIMENTAL

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

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

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.
• 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.

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 (including, but not limited to, small bowel tumors, symptomatic intestinal adhesions, symptomatic active ulcerations, and radiation enteritis).
• Known hypersensitivity to any component of the ingestible ID-Capsule (including, but not limited to, gelatin, polyimide, magnesium, or silver).
• 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.
• Any laboratory test result deemed clinical significant by the Investigator.

Sponsors & Collaborators

• EtectRX, Inc.: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Miami, Florida, 33126, 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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a prospective, open label, clinical study evaluating the safety and effectiveness of the ID-Cap System under direct observation in the clinical setting.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: July 31, 2018
• Primary Completion: November 15, 2018
• Study Completion: December 15, 2018
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)