Healthy VolunteersNCT03475485
ID-Cap System Under Direct Observation
A study testing ID-Capsule- Active and Wearable Sensor in people with Healthy Volunteers, run by EtectRX, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ID-Capsule- Active and Wearable Sensor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 18 years of age or older.
- 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)
Who cannot join
- 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
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of the ID-Cap System, an Ingestion Event Marker, in the Clinical Setting as an Aid to Measure Medication Adherence
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.
- Conditions
- Healthy Volunteers
- Being tested
- ID-Capsule- Active, Wearable Sensor, Placebo
- Keywords
- Ingestion event marker, Ingestible sensor, Medication adherence, ID-Cap Medication Adherence Feedback System
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID-Capsule- ActiveDevice
A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
Wearable SensorDevice
Subjects will wear an ID-Reader
PlaceboDevice
A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.
| Study group | Role | What they receive |
|---|---|---|
| ID-Capsules- Active | Experimental | 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. Receives: Device: ID-Capsule- Active; Device: Wearable Sensor |
| ID-Capsules- Inactive | Placebo comparator | 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. Receives: Device: Wearable Sensor; Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Detection Accuracy (PDA)
The number of active ingestible sensors detected divided by the number of active ingestible sensors administered under direct observation.
Measured: 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.
Measured: Up to 10 days
Secondary outcomes (1)
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
Measured: Up to 10 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start22 Mar 2018
- Primary completion1 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a prospective, blinded, clinical study evaluating the safety and effectiveness of the ID-Cap System under direct observation in the clinical setting. Subjects will ingest a series of active ID capsules containing ingestible sensors and a series of empty placebo capsules that will be randomly administered. The ID-Capsule System's feasibility/ability to properly record actual ingestions (Positive Detection Accuracy) and to not record blank ingestions (Negative Detection Accuracy) will be evaluated.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- EtectRX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Connor, RN, Study director, EtectRX, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475485
- Sponsor's protocol ID
- ERX001
- Status last verified
- Jun 2018
- First submitted
- 18 Mar 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the ID-Cap System, an Ingestion Event Marker, in the Clinical Setting as an Aid to Measure Medication Adherence
- ClinicalTrials.gov ID
- NCT03475485
- Acronym / sponsor ID
- ERX001
- Conditions
- Healthy Volunteers
- Keywords
- Ingestion event marker, Ingestible sensor, Medication adherence, ID-Cap Medication Adherence Feedback System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- EtectRX, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, blinded, clinical study evaluating the safety and effectiveness of the ID-Cap System under direct observation in the clinical setting. Subjects will ingest a series of active ID capsules containing ingestible sensors and a series of empty placebo capsules that will be randomly administered. The ID-Capsule System's feasibility/ability to properly record actual ingestions (Positive Detection Accuracy) and to not record blank ingestions (Negative Detection Accuracy) will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| ID-Capsules- Active | Experimental | Device: ID-Capsule- Active, Device: Wearable SensorRandomly-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-Capsules- Inactive | Placebo comparator | Device: Wearable Sensor, Device: PlaceboRandomly-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 (defined for investigator in protocol)
Key exclusion criteria (8 listed)
- 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
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ID-Capsule- ActiveA standard gelatin or HPMC capsule with an embedded ingestible wireless sensor. | Device | ID-Capsules- Active |
| Wearable SensorSubjects will wear an ID-Reader | Device | ID-Capsules- Active, ID-Capsules- Inactive |
| PlaceboA standard gelatin or HPMC capsule without an embedded ingestible wireless sensor. | Device | ID-Capsules- Inactive |
Primary outcome
Positive Detection Accuracy (PDA)
Time frame: Up to 10 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 10 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.
1 secondary outcome
Number of Study Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 10 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Connor, RN study director
EtectRX, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ID-Capsule- Active and Wearable Sensor in people with Healthy Volunteers, run by EtectRX, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Detection Accuracy (PDA) (time frame: Up to 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.