CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
MIND1 Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02404532
NCT02404532Phase 4Completed
CompareCT.gov

OSMITTER 316-13-206B Substudy: A Substudy to Measure the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1) System and Determine the Latency Period

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Mar 31, 2015·Updated Aug 3, 2018

In Brief

A Phase 4 clinical trial evaluating MIND1 System for Device Latency. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDevice Latency
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 31, 2015
Enrollment StartFeb 1, 2015
Primary CompletionFeb 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.3 years ago

Interventions

MIND1 Systemdevice

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).