MedTrace Logo

Pediatric Adhesion and New Dermal Approach Study

NCT07118124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Zio monitor

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

Sponsors & Collaborators

  • iRhythm Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles Berul, MD · Children's National Research Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2025-09-26
Completion
2026-01-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118124 on ClinicalTrials.gov