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Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)

NCT02404532 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-03

Study results available
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Summary

The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.

Conditions

  • Device Latency

Interventions

DEVICE

MIND1 System

Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Subjects may eat as they wish over the course of the day. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Clinic staff will record the time of each ingestion of an IEM. Clinic staff will check the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and will record the time it is detected by the MIND1 System compatible computing device (eg, smartphone).

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Timothy Peters-Strickland, MD · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-02-28
Completion
2015-03-31

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 NCT02404532 on ClinicalTrials.gov