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Pre-Market Algorithm Validation Study

NCT02200601 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-02-13

No results posted yet for this study

Summary

The study sponsor has developed a patented medical device called Seipher Wellness. This is a non-invasive medical device that assesses heart health based on established cardiac parameters; timing events of the cardiac cycle. These are specific parameters captured and analyzed by the device. A ratio of two specific timing parameters provides an assessment of the subject's overall heart health. The aim of this study is to validate the device algorithm across a range of subjects.

Conditions

  • Healthy

Interventions

DEVICE

Seipher Wellness

Sponsors & Collaborators

  • Heart Force Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Geoff Houlton, MB ChB · Heart Force Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Canada

Study Locations

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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 NCT02200601 on ClinicalTrials.gov