Pre-Market Algorithm Validation Study

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Seipher Wellness

• Registration Number: NCT02200601
• Lead Sponsor: Heart Force Medical Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seipher Wellness	Seipher Wellness	-

Primary Outcome Measures

Name	Time	Method
Systolic Time Intervals (STI) value	Day 1

Trial Locations

Locations (1)

Integrative Naturopathic Medical Centre; 🇨🇦 Vancouver, British Columbia, Canada