- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03653897
Performance of the ID-Cap System, an Ingestion Event Marker, in the Clinical Setting as an Aid to Measure Medication Adherence
July 31, 2020 updated by: EtectRX, Inc.
Performance of the ID-Cap System, in the Clinical Setting as an Aid to Measure Medication Adherence (DO Trial 2.0)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33126
- Quotient Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Enrollment will be stratified to include at least two study participants in each BMI-Gender category. 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
Subjects will wear an ID-Reader
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Detection Accuracy (PDA)
Time Frame: Up to 6 days
|
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)
Time Frame: Up to 6 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Study Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 6 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion]
|
Incidence of mild, moderate, and severe adverse events overall and related to the device; discontinuations due to adverse events
|
Up to 6 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion]
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection Time
Time Frame: Up to 60 minutes post ingestion
|
Time from ingestion of ID-Capsule to first detection by the ID-Cap Reader
|
Up to 60 minutes post ingestion
|
Signal Duration
Time Frame: Up to 60 minutes post ingestion
|
Time from first to last detection of the signal from the ingested sensor by the ID-Cap Reader
|
Up to 60 minutes post ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Gary Connor, RN, EtectRX, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2018
Primary Completion (Actual)
November 15, 2018
Study Completion (Actual)
December 15, 2018
Study Registration Dates
First Submitted
August 28, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (Actual)
August 31, 2018
Study Record Updates
Last Update Posted (Actual)
August 4, 2020
Last Update Submitted That Met QC Criteria
July 31, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ERX002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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