At a glance
ClinicalIndex Comparison RecordN/ACompleted· 18 enrolled
Drug / intervention
Serkel 3D CROdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study - to Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly, a Pre-market Fitting
University of Texas Southwestern Medical Center·interventional·Posted Feb 18, 2025·Updated May 16, 2025
In Brief
A clinical study evaluating Serkel 3D CRO for Plagiocephaly, Nonsynostotic. Completed, enrolled 18 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlagiocephaly, Nonsynostotic
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
Enrollment StartMay 2022
Primary CompletionApr 2024
First PostedFeb 2025
TodayJul 2026
First PostedFeb 18, 2025
Enrollment StartMay 24, 2022
Primary CompletionApr 5, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 1.4 years ago
Interventions
Serkel 3D CROdevice
Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis