Performance of the ID-Cap System, an Ingestion Event Marker, in the Clinical Setting as an Aid to Measure Medication Adherence
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|ClinicalTrials.gov Identifier: NCT03653897|
Recruitment Status : Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Device: ID-Capsule- Active Device: Wearable Sensor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||Performance of the ID-Cap System, in the Clinical Setting as an Aid to Measure Medication Adherence (DO Trial 2.0)|
|Actual Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||September 15, 2018|
|Estimated Study Completion Date :||October 15, 2018|
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.
Device: ID-Capsule- Active
A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
Device: Wearable Sensor
Subjects will wear an ID-Reader
- 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.
- 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.
- 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
- Detection Time [ Time Frame: Up to 60 minutes post ingestion ]Time from ingestion of ID-Capsule to first detection by the ID-Cap Reader
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653897
|United States, Florida|
|Miami, Florida, United States, 33126|
|Study Director:||Gary Connor, RN||EtectRX, Inc.|