Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Feb 12, 2025

Keywords

ClinConnect Summary

The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market. Serkel is an Australian company that specializes in the fabrication of 3D printed cranial remolding orthoses (CRO) to treat infants with deformational head shapes. Serkel has made over 600 helmets that have treated children with deformational head shapes in Australia, however it's specific helmet design is not FDA approved to provide treatment in the United States market. Serkel is seeking FDA approval of t...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants between the ages of 4-18 months at evaluation
• • Participants with physician prescription of CRO treatment
• • Participants with physician diagnosis of deformational plagiocephaly
• • Participants who skulls measurements qualify them for standard CRO treatment (CVA measurement is greater than 6mm and Cephalic Index is greater than 92%)
• Exclusion Criteria:
• • Participants younger than 4 months at evaluation
• • Participants older than 18 months at evaluation
• • Participants without physician prescription for CRO treatment
• • Participants without physician diagnosis of deformational plagiocephaly
• • Participants whos skull measurements or asymmetries do not qualify them for standard CRO treatment