Plagiocephaly, NonsynostoticNCT06831513
Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
A study testing Serkel 3D CRO in people with Plagiocephaly, Nonsynostotic, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Plagiocephaly, Nonsynostotic
- What is being tested?
- Serkel 3D CRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 5 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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%)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
UTSouthwestern University - School of Health Professions
Dallas, Texas, 75390
About this study
Official title: A Pilot Study - to Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly, a Pre-market Fitting
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
Read the detailed 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).
- Conditions
- Plagiocephaly, Nonsynostotic
- Being tested
- Serkel 3D CRO
- Medical subject headings
- Plagiocephaly, Nonsynostotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serkel 3D CRODevice
Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis
| Study group | Role | What they receive |
|---|---|---|
| Serkel 3D CRO Arm | Other | 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. Receives: Device: Serkel 3D CRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cranial Measurements as Measured by CVA
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.
Measured: Baseline, approximately 4-6 months
Change in Cranial Measurements as Measured by Cephalic Index
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.
Measured: Baseline, approximately 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start24 May 2022
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plagiocephaly, NonsynostoticStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants with deformational plagiocephaly, who qualify for cranial remolding treatment were fitted with a (new to US market) 3D printed cranial remolding orthosis.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dara Spivey, University of Texas Southwestern Medical Center
- Investigators
- Dara Spivey, MSOP, Principal investigator, University of Texas Southwestern Prosthetics Orthotics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831513
- Sponsor's protocol ID
- STU-2022-0287
- Status last verified
- Apr 2025
- First submitted
- 12 Feb 2025
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study - to Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly, a Pre-market Fitting
- ClinicalTrials.gov ID
- NCT06831513
- Acronym / sponsor ID
- STU-2022-0287
- Conditions
- Plagiocephaly, Nonsynostotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants with deformational plagiocephaly, who qualify for cranial remolding treatment were fitted with a (new to US market) 3D printed cranial remolding orthosis.
| Arm | Type | Receives |
|---|---|---|
| Serkel 3D CRO Arm | Other | Device: Serkel 3D CROOnce 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. |
Who may qualify
- Ages
- 4 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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%)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serkel 3D CROSerkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis | Device | Serkel 3D CRO Arm |
Primary outcome
Change in Cranial Measurements as Measured by CVA
Time frame: 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. * 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.
Change in Cranial Measurements as Measured by Cephalic Index
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dara Spivey, MSOP principal investigator
University of Texas Southwestern Prosthetics Orthotics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serkel 3D CRO in people with Plagiocephaly, Nonsynostotic, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cranial Measurements as Measured by CVA (time frame: Baseline, approximately 4-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.