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Study to Evaluate the Performance of CardiacSense PPG Sensor

NCT04353453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-04-20

No results posted yet for this study

Summary

study to evaluate the performance of the CardiacSense1's embedded PPG under different environmental and physical conditions

Conditions

Interventions

DEVICE

Study Procedure for Participants That Were Not in the Driving Group

Subjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition: 1. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius. 2. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius. 3. Sitting down for 10 minutes,outdoor walking for one minute and repeat this sequence four times At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor

DEVICE

Study Procedure for Participants That Were Included in the Driving Group

Subjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition: 1. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius. 2. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius. 3. Going from the indoor facility to the car and driving for 30 minutes at least. Subject drove the car in city streets under light traffic conditions. At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor

Sponsors & Collaborators

  • CardiacSense Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2019-03-18
Completion
2019-03-18

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 NCT04353453 on ClinicalTrials.gov