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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serkel 3D CRO | Device | Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 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.
| Baseline, approximately 4-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dara Spivey, MSOP | University of Texas Southwestern Prosthetics Orthotics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTSouthwestern University - School of Health Professions | Dallas | Texas | 75390 | United States |
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19 subjects consented but 1 screen failed and did not start treatment with the device. Therefore, only 18 considered enrolled and started treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
| Posted | Mean | Full Range | mm | Baseline, approximately 4-6 months |
|
Adverse events data collection occurred every 2 or 3 weeks throughout the time the subject was enrolled in the trial. Subjects enrollment/treatment time varied based on age and severity of skull deformation. On average subjects were enrolled and receiving treatment for 22 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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A limitation was not having statistical analysis planned. Only a descriptive analysis was performed (start and completion of head shape measurements) and study was intended to collect de-identified data on a small sample size and never intended to publish.
The funding sponsor, Serkel, went bankrupt and the company dissolved shortly after trials were complete, the final de-indentified data was not shared with Serkel.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dara Spivey, CPO, LPO | UT Southwestern Medical Center - School of Health Professions | (214) 645-8250 | dara.spivey@utsouthwestern.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2022 | Apr 7, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D049068 | Plagiocephaly, Nonsynostotic |
| ID | Term |
|---|---|
| D059041 | Plagiocephaly |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
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Participants with deformational plagiocephaly, who qualify for cranial remolding treatment were fitted with a (new to US market) 3D printed cranial remolding orthosis.
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| Participants |
|
| Age, Continuous | Mean | Full Range | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Primary | 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.
| Posted | Mean | Full Range | percentage | Baseline, approximately 4-6 months |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |