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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653897
Recruitment Status : Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Quotient Sciences
Information provided by (Responsible Party):
EtectRX, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: ID-Capsule- Active Device: Wearable Sensor Not Applicable

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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)
Primary Purpose: Other
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

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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Detection Time [ Time Frame: Up to 60 minutes post ingestion ]
    Time from ingestion of ID-Capsule to first detection by the ID-Cap Reader

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender at birth
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Florida
Quotient Sciences
Miami, Florida, United States, 33126
Sponsors and Collaborators
EtectRX, Inc.
Quotient Sciences
Investigators
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Study Director: Gary Connor, RN EtectRX, Inc.

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Responsible Party: EtectRX, Inc.
ClinicalTrials.gov Identifier: NCT03653897    
Other Study ID Numbers: ERX002
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by EtectRX, Inc.:
Ingestion event marker
Ingestible sensor
Medication adherence
ID-Cap Medication Adherence Feedback System