An interventional study of ID-Capsule- Active and Wearable Sensor in Healthy Volunteers, sponsored by EtectRX, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-11.
Sponsored by EtectRX, Inc. · Not applicable, Interventional, and Device feasibility
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.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's enrollment of 36 is below the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →EtectRX, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stratification for gender and 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: ID-Capsule- Active · Device: Wearable Sensor
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.
Device: Wearable Sensor · Device: Placebo
A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
Subjects will wear an ID-Reader
A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.
Positive Detection Accuracy (PDA)
The number of active ingestible sensors detected divided by the number of active ingestible sensors administered under direct observation.
Time frame: Up to 10 days
Negative Detection Accuracy (NDA)
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.
Time frame: Up to 10 days
Number of Study Participants with Adverse Events as a Measure of Safety and Tolerability
Incidence of mild, moderate, and severe adverse events overall and related to the device; discontinuations due to adverse events
Time frame: Up to 10 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion
Gender/BMI Effects
Effect of gender/BMI on the positive detection accuracy (covariate analysis) and other device performance measures
Time frame: Up to 10 Days
Detection time
Time from ingestion of ID-Capsule to first detection by the ID-Cap Reader
Time frame: Up to 60 minutes post ingestion
Signal Duration
Time from first to last detection of the signal from the ingested sensor by the ID-Cap Reader
Time frame: Up to 90 minutes post ingestion
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in May 2018, 1 month.
Of 442 interventional studies with no phase under Medication Adherence, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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EtectRX, Inc.