Monitoring Medication Adherence in Left Ventricular Assist Device Recipients
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ClinicalTrials.gov Identifier: NCT02388386 |
Recruitment Status :
Completed
First Posted : March 17, 2015
Results First Posted : November 17, 2020
Last Update Posted : November 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure Medication Compliance | Device: PROTEUS-SENSOR | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Pilot Study of Wireless Observed Therapy With an Ingestible Micro-Sensor Among Patients With Heart Failure and Left Ventricular Assist Devices |
Study Start Date : | February 2015 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

Arm | Intervention/treatment |
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Experimental: PROTEUS-SENSOR
The current study is a prospective interventional design with a single experimental arm. The intervention consists of two components: an edible sensor and a wearable receiver health monitor.
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Device: PROTEUS-SENSOR
An edible sensor system, Proteus Digital™ has been developed for electronically confirming medication adherence, gathering physiologic metrics and communicating these data to patients. The system consists of two major components: an edible sensor and a wearable receiver health monitor. An electrical signal is activated upon ingestion of the Proteus Digital micro-sensor with transmission of this signal to a receiving abdominal patch to quantify medication compliance. |
- System Performance - Positive Detection Accuracy [ Time Frame: 30 minutes after ingestion ]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
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From time of ingestion to 30 minutes after ingestion ]
Specific safety metrics will consist of the following composite outcome:
- Safety as measured by vital signs
- Cardiac rhythm monitoring review for arrhythmias
- LVAD device interrogation for changes in device parameters
- Implantable cardioverter defibrillator interrogation for arrhythmia occurrence

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing LVAD implantation for end-stage heart failure or admitted from the out-patient setting
Exclusion Criteria:
- Unable to consistently consume oral intake
- Hemodynamic instability defined as hypotension requiring intravenous vasoactive medications or arrhythmias requiring intravenous antiarrhythmics or oral antiarrhythmics for rhythm stabilization
- Gastrointestinal bleeding requiring intravenous gastric acid secretion inhibitors

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388386
United States, California | |
Scripps Health | |
San Diego, California, United States, 92037 |
Principal Investigator: | Sanjeev Bhavnani, MD | Scripps Clinic |
Responsible Party: | Scripps Translational Science Institute |
ClinicalTrials.gov Identifier: | NCT02388386 |
Other Study ID Numbers: |
PROTEUS-LVAD |
First Posted: | March 17, 2015 Key Record Dates |
Results First Posted: | November 17, 2020 |
Last Update Posted: | November 17, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data will be made available upon request |
Telemedicine Mobile Health |
Heart Failure Heart Diseases Cardiovascular Diseases |