U.S., Feb. 19 -- ClinicalTrials.gov registry received information related to the study (NCT06831513) titled 'A Pilot Study - to Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly, a Pre-market Fitting' on Feb. 12.
Brief 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 Start Date: May 24, 2022
Study Type: INTERVENTIONAL
Condition:
Plagiocephaly, Nonsynostotic
Intervention:
DEVICE: Serkel 3D CRO
Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis
Recruitmen...