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The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection

NCT01913561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-08-08

No results posted yet for this study

Summary

The Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG.

The electrodes are dry, textile ECG electrodes. The garment is designed to position the electrodes in the appropriate anatomical locations, without any special guidance. The dry electrodes are made from unique yarns with silver embedded into the garment using a proprietary technique developed by HealthWatch (HW)that obviates the need for skin preparation or the application of fluids. The garment can be connected to any standard ECG device available in the hospitals.

The purpose of this study is to evaluate the safety and effectiveness of the Master Caution Garment for continuous monitoring of ECG signal compared to standard gel electrodes.

The following endpoints will be evaluated in subjects participating in the study:

Primary:

Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes using standard ECG devices.

Secondary:

Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes when event is detected by the ECG devices.

Conditions

Interventions

DEVICE

Master Caution Garment

Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG. The electrodes are dry, textile ECG electrodes.

DEVICE

ECG gel electrodes

Standard gel electrodes that are been in use in hospital for ECG monitoring.

Sponsors & Collaborators

  • HealthWatch Ltd.

    lead INDUSTRY

Principal Investigators

  • Robert Zukerman, Dr. · Rambam medical center Haifa, Israel

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-06-30
Completion
2017-08-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT01913561 on ClinicalTrials.gov