Pre-Market Algorithm Validation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cardiovascular Precision Medicine & Remote Intervention

NCT05814562

Hypertension

COMPLETED NA

Assessment of Heart Rate Measurement Accuracy for the PreemptiveAI SDK in Adults

NCT06696339

Heart Rate in the General Public

ACTIVE_NOT_RECRUITING

The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS

NCT01845506

Fever COPD Obesity +2 more

UNKNOWN NA

Home Monitoring Study for Surgical Patients

NCT07231653

Patient Monitoring Postoperative Period

NOT_YET_RECRUITING

Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer

NCT03614416

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Seipher Wellness

Group Type EXPERIMENTAL

Seipher Wellness

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Seipher Wellness

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes