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

NCT ID: NCT03653897

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2018-12-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ID-Capsules- Active

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.

Group Type: EXPERIMENTAL

ID-Capsule- Active

Intervention Type: DEVICE

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

Wearable Sensor

Intervention Type: DEVICE

Subjects will wear an ID-Reader

Interventions

ID-Capsule- Active

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

Intervention Type: DEVICE

Wearable Sensor

Subjects will wear an ID-Reader

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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 (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.
• Positive screen for drugs of abuse (detection of drug for which a valid prescription exists is not exclusionary).
• Any laboratory test result deemed clinical significant by the Investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quotient Sciences

INDUSTRY

Sponsor Role: collaborator

EtectRX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Connor, RN

Role: STUDY_DIRECTOR

EtectRX, Inc.

Locations

Quotient Sciences

Miami, Florida, United States

Countries

United States

Other Identifiers

ERX002

Identifier Type: -

Identifier Source: org_study_id