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

The University of Texas System (UT)

Status: Completed

Conditions: Plagiocephaly, Nonsynostotic

Treatments: Device: Serkel 3D CRO

Study type: Interventional

Funder types: Other

Identifiers

NCT06831513

STU-2022-0287

Details and patient eligibility

About

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

Full description

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 their brand of CRO by providing CRO's for pre market fitting. The study includes treatment for children who have been screened and diagnosed with a positional deformational head shape. Those who qualify for a FDA approved CRO treatment and were given the option to participate in the study. If they were interested, an inform consent provided and reviewed together. Cargivers then had the option to enroll. In total, 18 participants were enrolled. Fabrication scans were taken of the subjects head, and they returned 2 weeks later for fitting of the 3D printed cranial remolding orthosis, and seen for follow up every 2-4 weeks until treatment was complete (head shape corrected or participant outgrew CRO).

Enrollment: 18 patients

Sex: All

Ages: 4 to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

Serkel 3D CRO Arm

Other group

Description:

Once parents/caregivers decide and consent for their child to participate and be treated with the pre-market Serkel 3D CRO, infant's head will be scanned and CRO will be fabricated and fitted 2 weeks later. The orthosis is nearly identical to existing FDA approved devices.

Treatment:

Device: Serkel 3D CRO