Pediatric Adhesion and New Dermal Approach Study

The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.

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Key information

Conditions

Syncope Arrhythmia Arrhythmia in Children Arrhythmias, Cardiac Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Athymia Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Consciousness Disorders Heart Defects, Congenital Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Signs and Symptoms Unconsciousness

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital, Washington D.C., District of Columbia, United States

About this study

This is a prospective single-arm study to demonstrate adequate analyzable time for use in pediatric patients up to 14 days of device wear. The study will incorporate a simplified skin preparation procedure. The objective is to evaluate analyzable time of the Zio® monitor device over the wear duration (up to 14 days) in a population 1 to 17 years of age. The study will incorporate a simplified skin preparation procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Child is <18 years of age and ≥1 year of age and weighing ≥10 kg (22 pounds) at the time of device application.
Child's legally authorized representative is willing and able to provide informed consent and be able to assist the Child in completing all visits for the study. If the Child is old enough to provide assent, it will also be captured.
The prescribed Zio monitor wear time is planned to be up to 14 days.

Exclusion criteria

Child has a known allergy to adhesives or hydrogels or with family history of adhesive skin allergies.
Child has a visible skin injury or broken skin at location for study device placement.
Child has skin damage and a discharge of clear fluid or pus at the location for study device placement.
Child is unable or unwilling to participate or comply with study protocol.
The local Investigator deems the Child has a condition that could limit the Child's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits. (It is understood that younger age groups of children may present development behavioral challenges in compliance with use of medical devices. Normal development stage should not be considered a reason for exclusion).
The child has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the child or when real-time or in-patient monitoring should be prescribed.
Child has an external or wearable cardiac defibrillator or may be exposed to high frequency surgical equipment near strong magnetic fields or devices such as MRI during the wear period.
Child has a neuro-stimulator, as it may disrupt the quality of ECG data.

Treatment and study plan

Zio monitor

Device

Evaluate analyzable time of the Zio monitor over the wear duration of up to 14 days in a pediatric population.

Primary outcomes

Performance Objective

Time frame: Up to 14 days

The duration of non-artifact ECG signal as a proportion of the device total wear time will be assessed. The sample proportion with analyzable time >80% is assumed to be 90%. The performance objective will be met if the lower bound of the 95% confidence interval is at least 75%. Percent analyzable time is defined as the duration of non-artifact ECG signal as a proportion of the device total wear time.

Other outcomes

Safety Measures

Time frame: From enrollment to the end of the device wear period

The proportion of participants that experience clinically significant skin irritation during wear will be assessed via a skin irritation assessment performed by the healthcare provider. All adhesive-based wearable devices may lead to skin irritation. Minor itching and redness are expected. Skin reaction during wear should be reported as an adverse event. Adverse events will be reported and assessed for severity and relationship to the study device.

Sponsors and collaborators

Lead sponsor

iRhythm Technologies, Inc.

Industry

Registry information

Official study title

Pediatric Adhesion and New Dermal Approach Study (PANDA)

Acronym: PANDA

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Aug 12, 2025
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed