Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2018-03-22
2018-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
TRIPLE
Study Groups
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ID-Capsules- Active
Randomly-assigned ingestions of ID-Capsules containing ingestible sensors (ID-Capsule- Active) while wearing the ID-Cap Reader (Wearable Sensor) under direct observation
• 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.
ID-Capsule- Active
A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
Wearable Sensor
Subjects will wear an ID-Reader
ID-Capsules- Inactive
Randomly-assigned ingestions of ID-Capsules containing no ingestible sensors while wearing the ID-Cap Reader under direct observation
• Subjects will also ingest empty placebo capsules that do not contain ingestible sensors. In the absence of an ingested sensor, no signal is received by the Reader after the capsule is ingested, and the ingestion event is not recorded.
Wearable Sensor
Subjects will wear an ID-Reader
Placebo
A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
Yes
Sponsors
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EtectRX, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gary Connor, RN
Role: STUDY_DIRECTOR
EtectRX, Inc.
Locations
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Quotient Sciences
Jacksonville, Florida, United States
Countries
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Other Identifiers
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ERX001
Identifier Type: -
Identifier Source: org_study_id
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