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NCT02388386 · ClinicalTrials.gov registry record · NA

Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

A NA study, sponsored by Scripps Translational Science Institute.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT02388386: Completed NA study, sponsored by Scripps Translational Science Institute.

NCT02388386 is a NA study that has completed, run by Scripps Translational Science Institute. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02388386, a NA study, has completed, sponsored by Scripps Translational Science Institute.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

The investigators aim to develop a novel and wireless method for monitoring medication adherence among heart failure patients with left ventricular assist devices (LVADs). Proteus Digital™ has developed an ingestible and bio-absorbable micro-sensor as a strategy to monitor medication compliance. The edible sensor has at its core a silicon-based integrated circuit measuring 1.0 mm x 0.45 mm and is imbedded on a pill. Once ingested, this circuit is activated by gastric acid resulting in an electrochemical redox reaction and an electrical charge that is transmitted to a patch worn over the abdomen and wirelessly to a portable device such as a smart phone. This strategy of medication adherence differs from conventional adherence monitoring including pill counting and patient-recall by precisely tracking medication ingestion.

Primary Outcome

Primary outcome measure of system performance will be estimated by the positive detection accuracy, defined as the number of ingestible sensors detected divided by those ingested

Interventions

  • DEVICE PROTEUS-SENSOR

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2015-02
Est. Completion 2016-04
Phase NA

What the finished NCT02388386 record still lists

NCT02388386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which PROTEUS-SENSOR is the first listed.

NCT02388386 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02388386 about?

NCT02388386 is a clinical study titled "Monitoring Medication Adherence in Left Ventricular Assist Device Recipients". The investigators aim to develop a novel and wireless method for monitoring medication adherence among heart failure patients with left ventricular assist devices (LVADs). Proteus Digital™ has developed an ingestible and bio-absorbable micro-sensor as a strategy to monitor medication compliance. The...

What is the current status of trial NCT02388386?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2015-02. Estimated completion is 2016-04.

What interventions are being tested in trial NCT02388386?

The interventions under investigation include: PROTEUS-SENSOR (DEVICE).

Who is sponsoring clinical trial NCT02388386?

This trial is sponsored by Scripps Translational Science Institute, which has 41 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02388386's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02388386, the US trial registry maintained by the National Library of Medicine. NCT02388386 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.