Pre-Market Algorithm Validation Study

Heart Force Medical

Status: Completed

Conditions: Healthy

Treatments: Device: Seipher Wellness

Study type: Interventional

Funder types: Industry

Identifiers

NCT02200601

SEIPHER_CLIN_002

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Seipher Wellness

Experimental group

Treatment:

Device: Seipher Wellness