Pre-Market Algorithm Validation Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02200601

Enrollment

Registered

2014-07-25

Start date

2014-07-31

Completion date

2015-02-28

Last updated

2015-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Seipher Wellness, algorithm, secure samples of SGC waveform, volunteers, validation, heart health algorithm

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.

Interventions

DEVICESeipher Wellness

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Systolic Time Intervals (STI) value	Day 1

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026