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ID-Cap System Under Direct Observation

NCT03475485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-06-11

No results posted yet for this 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.

Conditions

  • Healthy Volunteers

Interventions

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

DEVICE

Placebo

A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.

Sponsors & Collaborators

  • EtectRX, Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Connor, RN · EtectRX, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-22
Primary Completion
2018-05-01
Completion
2018-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03475485 on ClinicalTrials.gov