Pediatric Adhesion and New Dermal Approach Study (PANDA)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Washington, D.c.
Children's National Hospital
NOT_YET_RECRUITING
Washington D.c.
Idaho
St. Luke's Children's Hospital
RECRUITING
Boise
Massachusetts
Boston Children's Hospital
NOT_YET_RECRUITING
Boston
Missouri
WashU Medicine
NOT_YET_RECRUITING
St Louis
Contact Information
Primary
Adina Sr. Clinical Research Project Manager
adina.muresan@irhythmtech.com
(888) 693-2401
Backup
Janet Sr. Clinical Research Project Manager
janet.flores@irhythmtech.com
(888) 693-2401
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2025-11
Participants
Target number of participants: 36
Treatments
Other: Single-arm study to analyzable time for use in pediatric patients up to 14 days
Zio monitor
Related Therapeutic Areas
Sponsors
Leads: iRhythm Technologies, Inc.

This content was sourced from clinicaltrials.gov