ID-Cap System Under Direct Observation

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475485
• Other study ID #: ERX001
• Status: Completed
• Phase: N/A
• Start date: March 22, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: EtectRX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• ID-Capsule- Active
A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
• Wearable Sensor
Subjects will wear an ID-Reader
• Placebo
A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.

Locations

Country	Name	City	State
United States	Quotient Sciences	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
EtectRX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender/BMI Effects	Effect of gender/BMI on the positive detection accuracy (covariate analysis) and other device performance measures	Up to 10 Days
Other	Detection time	Time from ingestion of ID-Capsule to first detection by the ID-Cap Reader	Up to 60 minutes post ingestion
Other	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
Primary	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
Primary	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	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