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Not yet recruiting NCT06762691

Cranial Remolding Orthosis Registry

— Observational Plagiocephaly Brachycephaly Asymmetric Head

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MyCRO Band, Traditional CRO.
Who it may be relevant to
Registry conditions: Plagiocephaly, Brachycephaly, Asymmetric Head. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device MyCRO Band
    A 3D-printed cranial remolding orthosis
  • Device Traditional CRO
    A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband

Primary outcome measures

  • Asymmetry Index [Time frame: Baseline to final follow up visit (est. 6 months)]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Patient is geographically inaccessible to comply and participate in the registry.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Wright & Filippis — Madison Heights

Identifiers

NCT: NCT06762691 · OB114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗