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New Stick-On heart monitor put to the test

NCT ID NCT07200232

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new wearable ECG sensor called the ZywieZ3 in 45 healthy adults. The sensor was compared to a standard hospital ECG device over one hour, then worn for 10 days to check signal quality and skin adhesion. Researchers also tested how different placements on the chest affected the readings. The goal was to see if the new sensor works as well as traditional monitors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZywieZ3 sensor and adhesive
What this could lead to
If successful, this could lead to a more comfortable and reliable wearable ECG monitor for home use.
What could go wrong
This is a small, early-stage study in healthy people only. It does not test diagnosis or treatment of any heart condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

45 people

The number who actually took part.

Started

Jan 2025

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Of the 25 subjects for Phase 1 and 2 and 20 subjects for Phase 3 who complete the study, at least 40% of subjects must be male, and at least 40% of the subjects must be female. * Of the 25 subjects for Phase 1 and 2 and 20 subjects for Phase 3 who complete the study, no more than 50% may be white/Caucasian, and at least 50% must be classified as each of the following races: Asian, Black / African American, American Indian / Alaskan Native, and Native Hawaiian / Pacific Islander. * Subjects must be 21 to 80 years of age. Of the 25 subjects for Phase 1 and 2 and 20 subjects for Phase 3 who complete the study, no more than 30% can be from a given quartile (21 to 36, 36 to 51, 51 to 65, and 65 to 80 year of age) of the age range. * Subjects' body mass index (BMI) will be calculated based on their weight and height at the time of consent. BMI will be calculated using the CDC's online Adult BMI Calculator. This calculator will also automatically categorize the calculated BMI as underweight (\< 18.5), healthy (18.5 to 24.9), overweight (25.0 to 29.9), or obese (≥ 30.0). Of the 25 subjects for Phase 1 and 2 and 20 subjects for Phase 3 who complete the study, no more than 30% can be from a given BMI category. * Subjects' education will be categorized as high school / GED, associate college degree, bachelor college degree, or post-graduate degree (e.g., M.S. or Ph.D.). Of the 25 subjects who complete Phases 1 and 2 of the study, no more than 7 subjects can be from a given educational level category. * Of the 25 subjects who complete Phases 1 and 2 of the study, at least 7 must self-report some type of limited hand/arm dexterity. * Subjects must be able to read, write, and understand English. * Subjects must be in good general health (i.e., no current or recent severe illness). * All subjects with body hair on their upper-left chest must be willing to have the body hair clipped by a Testing Facility analyst before application of the Test Device. * Subjects participating in Phase 1 must be willing to have the body hair clipped by a Testing Facility analyst from the right clavicular region and middle of their left rib cage. * Subjects participating in Phases 1 and 2 must be willing to clean the skin of the right clavicular region, upper-left chest, and middle of their left rib cage with 70% isopropanol preparation pads prior to their application of the Test Device and application of the Reference Device by a Testing Facility analyst. Subjects participating in Phase 3 must be willing to clean the skin of the upper-left chest with 70% isopropanol preparation pads before application of the Test Device. Exclusion Criteria: * Subjects cannot be currently participating in another clinical study. * Subjects cannot have active skin rashes, dermatoses, or breaks in the skin on their clavicles, and the middle of their left rib cage for Phase 1 and 2 or on the upper left chest region for all phases. * Subjects cannot have undergone any surgeries during the last 3 months involving incisions along their clavicles and the middle of their left rib cage for Phase 1 and Phase 2 or on the upper left chest region for all phases. * Subjects cannot have any tattoos on their clavicles and the middle of their left rib cage for Phase 1 and Phase 2 or on the upper left chest region for all phases. * Subjects cannot have currently inflammatory skin conditions (e.g., atopic dermatitis/eczema, contact dermatitis, or psoriasis) anywhere on the body within 2 days of the start of the test period and during the test period. * Subjects cannot have a medical diagnosis of an organ transplant, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis. * Subjects cannot have a pacemaker. * Subjects cannot have any type of port, shunt, or Peripherally Inserted Central Catheter (PICC). * Subjects cannot receive any vaccinations within 7 days of the start of the test period and while participating in the single-day or 10-day test period. * Subjects cannot have known allergies or sensitivities to latex (natural rubber), adhesives, inks, sunscreens, deodorants, laundry detergents, cleansers, soaps, lotions, to topical application of fragrances (e.g., perfumes or colognes), acrylic, hydrogel, isopropyl alcohol, C11-12 isoparaffin, isopropyl palmitate, isopropyl myristate, or isopropyl stearate. * Subjects participating in Phases 1 and 2 cannot use antihistamines within 2 days of the start of the test period through to the completion of the 10-day test period, which may interfere with the evaluation of skin reactions after application of the devices. * Subjects cannot be pregnant or plan to become pregnant / impregnate a sexual partner during the study. * Subjects cannot be nursing a child during the study. * Subjects cannot have any medical condition or use any medications that, in the opinion of the Principal Investigator or Consulting Physicians, should preclude participation.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Bioscience of Bozeman, LLC

    Bozeman, Montana, 59715, United States

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