NCT07118124

Pediatric Adhesion and New Dermal Approach Study

Pediatric Adhesion and New Dermal Approach Study (PANDA)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: iRhythm Technologies, Inc. · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Syncope
• Pediatric
• Congenital Athymia
• Congenital Heart Disease
• Arrhythmia
• Arrhythmia in Children

Interventions

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

Timeline

• Start date: 2025-08-15
• Primary completion: 2025-09-30
• Completion: 2026-03-01
• First posted: 2025-08-12
• Last updated: 2026-02-19

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study