Trials / Not Yet Recruiting
Not Yet RecruitingNCT06762691
Cranial Remolding Orthosis Registry
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Otto Bock HealthCare LP · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MyCRO Band | A 3D-printed cranial remolding orthosis |
| DEVICE | Traditional CRO | A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2030-04-01
- Completion
- 2030-04-01
- First posted
- 2025-01-07
- Last updated
- 2025-01-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06762691. Inclusion in this directory is not an endorsement.