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Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly

NCT06831513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-16

Study results available
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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

Conditions

  • Plagiocephaly, Nonsynostotic

Interventions

DEVICE

Serkel 3D CRO

Serkel 3D CRO is intervention for those with deformational plagiocephaly and already qualified for a cranial remolding orthosis

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Dara Spivey, MSOP · University of Texas Southwestern Prosthetics Orthotics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2024-04-05
Completion
2024-04-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06831513 on ClinicalTrials.gov