HealthyNCT02200601
Pre-Market Algorithm Validation Study
A study testing Seipher Wellness in people with Healthy, run by Heart Force Medical Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Seipher Wellness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- able to understand the informed consent document
- willing to participate
- ambulatory volunteers
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Integrative Naturopathic Medical Centre
Vancouver, British Columbia, V6H 3X8
About this study
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
- Being tested
- Seipher Wellness
- Keywords
- Seipher Wellness, algorithm, secure samples of SGC waveform, volunteers, validation, heart health algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seipher WellnessDevice
| Study group | Role | What they receive |
|---|---|---|
| Seipher Wellness | Experimental | Not described Receives: Device: Seipher Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Time Intervals (STI) value
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Force Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoff Houlton, MB ChB, Principal investigator, Heart Force Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200601
- Sponsor's protocol ID
- SEIPHER_CLIN_002
- Status last verified
- Feb 2015
- First submitted
- 23 Jul 2014
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Market Algorithm Validation Study
- ClinicalTrials.gov ID
- NCT02200601
- Acronym / sponsor ID
- SEIPHER_CLIN_002
- Conditions
- Healthy
- Keywords
- Seipher Wellness, algorithm, secure samples of SGC waveform, volunteers, validation, heart health algorithm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Heart Force Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seipher Wellness | Experimental | Device: Seipher Wellness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- able to understand the informed consent document
- willing to participate
- ambulatory volunteers
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seipher Wellness | Device | Seipher Wellness |
Primary outcome
Systolic Time Intervals (STI) value
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoff Houlton, MB ChB principal investigator
Heart Force Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seipher Wellness in people with Healthy, run by Heart Force Medical Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Time Intervals (STI) value (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015; AzTrials last refreshed its copy on 27 Oct 2026.