PlagiocephalyNCT06762691
Cranial Remolding Orthosis Registry
An observational study of Plagiocephaly and Brachycephaly, run by Otto Bock HealthCare LP at 1 site in United States.
Trial summary
A registry of infants fitted with a cranial remolding orthosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Plagiocephaly, Brachycephaly, Asymmetric Head
- What is being tested?
- MyCRO Band and Traditional CRO
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2025to Apr 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All infants who have been scanned and fitted with a cranial remolding orthosis
Who may be able to join
- Patient has been evaluated and successfully scanned for a MyCRO Band or similar CRO
- Patient's parent(s) or legal guardian(s) are able to communicate, provide feedback, understand and follow instructions during the course of the registry.
- Parent(s) or legal guardian(s) are willing to provide informed consent.
Who cannot join
- Patient is geographically inaccessible to comply and participate in the registry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
A registry of infants fitted with a cranial remolding orthosis.
Read the detailed description
The intention of the CRO registry is to gather real-world data of traditional and 3D-printed cranial remolding orthoses to compare outcomes.
- Conditions
- Plagiocephaly, Brachycephaly, Asymmetric Head
- Being tested
- MyCRO Band, Traditional CRO
- Keywords
- CRO, MyCRO, Cranial Helmet, Cranial Orthosis, Cranial Remolding Orthosis
- Medical subject headings
- Plagiocephaly, Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyCRO BandDevice
A 3D-printed cranial remolding orthosis
Traditional CRODevice
A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband
| Study group | Role | What they receive |
|---|---|---|
| Plagiocephaly | Infants diagnosed with plagiocephaly who have been scanned for a cranial remolding orthosis Receives: Device: MyCRO Band; Device: Traditional CRO | |
| Brachycephaly | Infants diagnosed with brachycephaly who have been scanned for a cranial remolding orthosis Receives: Device: MyCRO Band; Device: Traditional CRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymmetry Index
Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly)
Measured: Baseline to final follow up visit (est. 6 months)
Secondary outcomes (2)
Orthosis Utilization
Orthosis wear time will be measured from an embedded sensor
Measured: Baseline to final follow up visit (est. 6 months)
QUEST 2.0
Quebec User Evaluation of Satisfaction with Assistive Technology 2.0
Measured: Final follow up visit (est. 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlagiocephalyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Otto Bock HealthCare LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762691
- Sponsor's protocol ID
- OB114
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No plans have been made to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Remolding Orthosis Registry
- ClinicalTrials.gov ID
- NCT06762691
- Acronym / sponsor ID
- OB114
- Conditions
- Plagiocephaly, Brachycephaly, Asymmetric Head
- Keywords
- CRO, MyCRO, Cranial Helmet, Cranial Orthosis, Cranial Remolding Orthosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Otto Bock HealthCare LPIndustry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A registry of infants fitted with a cranial remolding orthosis.
Detailed description
The intention of the CRO registry is to gather real-world data of traditional and 3D-printed cranial remolding orthoses to compare outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plagiocephaly | – | Device: MyCRO Band, Device: Traditional CROInfants diagnosed with plagiocephaly who have been scanned for a cranial remolding orthosis |
| Brachycephaly | – | Device: MyCRO Band, Device: Traditional CROInfants diagnosed with brachycephaly who have been scanned for a cranial remolding orthosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All infants who have been scanned and fitted with a cranial remolding orthosis
Key inclusion criteria (3 listed)
- Patient has been evaluated and successfully scanned for a MyCRO Band or similar CRO
- Patient's parent(s) or legal guardian(s) are able to communicate, provide feedback, understand and follow instructions during the course of the registry.
- Parent(s) or legal guardian(s) are willing to provide informed consent.
Key exclusion criteria (1 listed)
- Patient is geographically inaccessible to comply and participate in the registry.
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 |
|---|---|---|
| MyCRO BandA 3D-printed cranial remolding orthosis | Device | Brachycephaly, Plagiocephaly |
| Traditional CROA traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband | Device | Brachycephaly, Plagiocephaly |
Primary outcome
Asymmetry Index
Time frame: Baseline to final follow up visit (est. 6 months)
Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly)
2 secondary outcomes
Orthosis Utilization
Time frame: Baseline to final follow up visit (est. 6 months)
QUEST 2.0
Time frame: Final follow up visit (est. 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided. No plans have been made to share IPD
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plagiocephaly and Brachycephaly, run by Otto Bock HealthCare LP 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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jared Howell (8328644322, jared.howell@ottobock.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymmetry Index (time frame: Baseline to final follow up visit (est. 6 months)). 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 7 Jan 2025; AzTrials last refreshed its copy on 1 Nov 2026.