N/A
N=18
Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
Plagiocephaly, Nonsynostotic
Bottom Line
View on ClinicalTrials.gov: NCT06831513 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Cranial Measurements as Measured by CVA — 11.6; 7.1 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Serkel 3D CRO (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cranial Measurements as Measured by CVA |
11.6; 7.1 | — |
| PRIMARY Change in Cranial Measurements as Measured by Cephalic Index |
89.8; 86.8 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT06831513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.