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NCT03475485 · ClinicalTrials.gov registry record · NA
ID-Cap System Under Direct Observation
A NA study of Healthy Volunteers, sponsored by EtectRX.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT03475485: Completed NA study of Healthy Volunteers, sponsored by EtectRX.
NCT03475485 is a NA study of Healthy Volunteers that has completed, run by EtectRX. The registered enrollment target is 36 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03475485, a NA study of Healthy Volunteers, has completed, sponsored by EtectRX.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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, 36 subjects will ingest capsules containing ingestible sensors while wearing the Reader and being observed in a clinic setting.
Primary Outcome
The number of active ingestible sensors detected divided by the number of active ingestible sensors administered under direct observation.
Conditions Studied
Interventions
- DEVICE Placebo
- DEVICE ID-Capsule- Active
- DEVICE Wearable Sensor
Study Locations (1)
Florida
- Quotient Sciences - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-03-22 |
| Est. Completion | 2018-06-01 |
| Phase | NA |
What the finished NCT03475485 record still lists
NCT03475485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03475485 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03475485 about?
NCT03475485 is a clinical study titled "ID-Cap System Under Direct Observation". 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...
What is the current status of trial NCT03475485?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2018-03-22. Estimated completion is 2018-06-01.
What conditions does trial NCT03475485 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03475485?
The interventions under investigation include: Placebo (DEVICE), ID-Capsule- Active (DEVICE), Wearable Sensor (DEVICE).
Who is sponsoring clinical trial NCT03475485?
This trial is sponsored by EtectRX, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03475485 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03475485's enrollment target sits among peer trials
36 166th of 283 higher than 115 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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