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Performance of the ID-Cap System, an Ingestion Event Marker, in the Clinical Setting as an Aid to Measure Medication Adherence

NCT03653897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-08-04

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, 12-18 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

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • EtectRX, Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Connor, RN · EtectRX, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2018-11-15
Completion
2018-12-15
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 NCT03653897 on ClinicalTrials.gov