Trial Outcomes & Findings for Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly (NCT NCT06831513)

Last Updated: 2025-05-16

Results Overview

Skull measurement are taken at every appointment the participant attends. At the end of treatment, the measurements will be compared to the participants starting measurements. Measurements can be taken by hand, using a tape measure and calipers. Or using an FDA approved scanner -- OMEGA Scanner 3D or Orthomerica STARscanner. * Cranial Vault Asymmetry (CVA) measures the difference between the lengths of two diagonals on the top of the skull. These diagonals are measured at a 30-degree angle from the midline. The CVA equation is: CVA = A - B, where A and B are the lengths of the longer and shorter diagonals, respectively. CVA is measured in millimeters.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Baseline, approximately 4-6 months

Results posted on

2025-05-16

Participant Flow

19 subjects consented but 1 screen failed and did not start treatment with the device. Therefore, only 18 considered enrolled and started treatment.

Participant milestones

Participant milestones
Measure	Serkel 3D CRO Arm 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. Serkel 3D CRO: Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Serkel 3D CRO Arm n=18 Participants 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. Serkel 3D CRO: Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis
Age, Categorical <=18 years	18 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30.4 weeks n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	6 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, approximately 4-6 months

Outcome measures

Outcome measures
Measure	Serkel 3D CRO Arm n=18 Participants 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. Serkel 3D CRO: Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis
Change in Cranial Measurements as Measured by CVA Cranial Vault Asymmetry at start of treatment	11.6 mm Interval 3.5 to 18.4
Change in Cranial Measurements as Measured by CVA Cranial Vault Asymmetry at end of treatment	7.1 mm Interval 0.2 to 16.1

PRIMARY outcome

Timeframe: Baseline, approximately 4-6 months

Skull measurement are taken at every appointment the participant attends. At the end of treatment, the measurements will be compared to the participants starting measurements. Measurements can be taken by hand, using a tape measure and calipers. Or using an FDA approved scanner -- OMEGA Scanner 3D or Orthomerica STARscanner. * The Cephalic Index (CI) is a measurement of head shape in infants, calculated by dividing head width by head length and multiplying by 100. A CI within the normal range (75-90%) indicates a typical head shape, while deviations, especially those leading to brachycephaly (CI \> 90%) or dolichocephaly (CI \< 76%), may be associated with developmental or medical concerns.

Outcome measures

Outcome measures
Measure	Serkel 3D CRO Arm n=18 Participants 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. Serkel 3D CRO: Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis
Change in Cranial Measurements as Measured by Cephalic Index Cephalic Index at start of treatment	89.8 percentage Interval 75.8 to 107.6
Change in Cranial Measurements as Measured by Cephalic Index Cephalic Index at end of treatment	86.8 percentage Interval 78.7 to 99.6

Adverse Events

Serkel 3D CRO Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dara Spivey, CPO, LPO

UT Southwestern Medical Center - School of Health Professions

Phone: (214) 645-8250

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place