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CompletedNo phase

Pediatric Adhesion and New Dermal Approach Study

Key facts

Who runs it
iRhythm Technologies, Inc.
Where
Boise, Boston, St Louis, and Washington D.C., United StatesSee the 4 sites
Trial code
Status
Completed
People taking part
36 people enrolled
Started
15 Aug 2025
Ended
13 Jan 2026
Type of study
Interventional
Treatments tested
  • Zio monitor
Record updated
6 May 2026

Who can take part

Age
1 year to 17 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Child has a known allergy to adhesives or hydrogels or with family history of adhesive skin allergies
  • 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
  • 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)
  • 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
  • Child has a neuro-stimulator, as it may disrupt the quality of ECG data

Where in United States

  • St. Luke's Children's HospitalBoise, United StatesNo longer taking part
  • Boston Children's HospitalBoston, United StatesNo longer taking part
  • WashU MedicineSt Louis, United StatesNo longer taking part
  • Children's National HospitalWashington D.C., United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • Single-arm study to analyzable time for use in pediatric patients up to 14 daysOther group

    Zio monitor

    Treatment: Zio monitor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pediatric Adhesion and New Dermal Approach Study (PANDA)
Record updated
6 May 2026