NCT02200601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

7 months

First QC Date

July 23, 2014

Last Update Submit

February 11, 2015

Conditions

Healthy

Keywords

Seipher Wellnessalgorithmsecure samples of SGC waveformvolunteersvalidationheart health algorithm

Outcome Measures

Primary Outcomes (1)

  • Systolic Time Intervals (STI) value

    Day 1

Study Arms (1)

Seipher Wellness

EXPERIMENTAL
Device: Seipher Wellness

Interventions

Seipher WellnessDEVICE
Seipher Wellness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Naturopathic Medical Centre

Vancouver, British Columbia, V6H 3X8, Canada

Location

Study Officials

  • Geoff Houlton, MB ChB

    Heart Force Medical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 25, 2014

Study Start

July 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

CA(1)