Trial Outcomes & Findings for Monitoring Medication Adherence in Left Ventricular Assist Device Recipients (NCT NCT02388386)
NCT ID: NCT02388386
Last Updated: 2020-11-17
Results Overview
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
COMPLETED
NA
10 participants
30 minutes after ingestion
2020-11-17
Participant Flow
Participant milestones
| Measure |
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.
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.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PROTEUS-SENSOR
n=10 Participants
10 consecutive heart failure patients with continuous flow left ventricular devices
|
|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 5 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after ingestionPrimary 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
Outcome measures
| Measure |
Outcome Measure
n=40 Ingestions
Positive detection rate of 80%
|
Cardiac Rhythm
Cardiac rhythm monitoring for arrhythmias
|
LVAD Device Interrogation
Change in LVAD device parameters
|
Implantable Cardioverter Defibrillator Interrogation
Assessment of cardiac arrhythmias by ICD interrogation
|
|---|---|---|---|---|
|
System Performance - Positive Detection Accuracy
|
80 percentage of ingestions
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From time of ingestion to 30 minutes after ingestionPopulation: Specific safety metrics will consist of the following composite outcome: 1. Safety as measured by vital signs 2. Cardiac rhythm monitoring review for arrhythmias 3. LVAD device interrogation for changes in device parameters 4. Implantable cardioverter defibrillator interrogation for arrhythmia occurrence
Specific safety metrics will consist of the following composite outcome: 1. Safety as measured by vital signs 2. Cardiac rhythm monitoring review for arrhythmias 3. LVAD device interrogation for changes in device parameters 4. Implantable cardioverter defibrillator interrogation for arrhythmia occurrence
Outcome measures
| Measure |
Outcome Measure
n=10 Participants
Positive detection rate of 80%
|
Cardiac Rhythm
n=10 Participants
Cardiac rhythm monitoring for arrhythmias
|
LVAD Device Interrogation
n=10 Participants
Change in LVAD device parameters
|
Implantable Cardioverter Defibrillator Interrogation
n=10 Participants
Assessment of cardiac arrhythmias by ICD interrogation
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PROTEUS-SENSOR
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place