Pre-Market Algorithm Validation Study

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Naturopathic Medical Centre

Vancouver, British Columbia, V6H 3X8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years or older
able to understand the informed consent document
willing to participate
ambulatory volunteers

Exclusion criteria

individuals with visible scar(s) or deformity in the test area of the chest
non-ambulatory subjects
enrolled in another concurrent study or trial
exercised excessively within the last 4 hours
unwilling to sign informed consent
female subjects who are pregnant, suspected or planning to become pregnant or breast-feeding

Treatment and study plan

Seipher Wellness

Device

Primary outcomes

Systolic Time Intervals (STI) value

Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Heart Force Medical Inc.

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jul 25, 2014
Registry last updated: Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed