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Pediatric Adhesion and New Dermal Approach Study
Sponsor: iRhythm Technologies, Inc.
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.
Official title: Pediatric Adhesion and New Dermal Approach Study (PANDA)
Key Details
Gender
All
Age Range
1 Year - 17 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-08-15
Completion Date
2026-03
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
Zio monitor
Evaluate analyzable time of the Zio monitor over the wear duration of up to 14 days in a pediatric population.
Locations (4)
Children's National Hospital
Washington D.C., District of Columbia, United States
St. Luke's Children's Hospital
Boise, Idaho, United States
Boston Children's Hospital
Boston, Massachusetts, United States
WashU Medicine
St Louis, Missouri, United States