Clinical trial NCT03475485: ID-Cap System Under Direct Observation
Official title: Clinical Performance of the ID-Cap System, an Ingestion Event Marker, in the Clinical Setting as an Aid to Measure Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Ingestion event marker
Ingestible sensor
Medication adherence
ID-Cap Medication Adherence Feedback System
Lead sponsor: EtectRX, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Positive Detection Accuracy (PDA)
timeFrame: Up to 10 days
measure: Negative Detection Accuracy (NDA)
timeFrame: Up to 10 days
Secondary outcomes:
measure: Number of Study Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 10 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion
Other outcomes:
measure: Gender/BMI Effects
timeFrame: Up to 10 Days
measure: Detection time
timeFrame: Up to 60 minutes post ingestion
measure: Signal Duration
timeFrame: Up to 90 minutes post ingestion
Locations:
city: Jacksonville
country: United States
facility: Quotient Sciences
state: Florida
Study officials:
affiliation: EtectRX, Inc.
name: Gary Connor, RN
role: STUDY_DIRECTOR
References: