NCT02200601

Pre-Market Algorithm Validation Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Heart Force Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	Seipher Wellness

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-07-25
• Last updated: 2015-02-13

Locations

1 site across 1 country: Canada