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NCT06425172 · ClinicalTrials.gov registry record
Monitoring System for Cranial Orthoses
A clinical trial of Plagiocephaly and Brachycephaly, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- 12
- Enrollment target
- 1
- Study location
NCT06425172: Recruiting study of Plagiocephaly and Brachycephaly, sponsored by University of Texas Southwestern Medical Center.
NCT06425172 is a study of Plagiocephaly and Brachycephaly that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 12 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06425172, a study of Plagiocephaly and Brachycephaly, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).
Primary Outcome
The temperature readings from the custom temperature sensor within the research helmet will be compared to the collected temperature readings from the iButtons. Using established software compatible with the iButton, wear time will be calculated based on previously reported temperature thresholds which indicate the helmet is being worn. Using similar temperature thresholds, wear time data from the custom sensors will be compared to the wear time reported by the iButton software.
Conditions Studied
Interventions
- DEVICE Cranial Remolding Orthosis
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2026-06-01 |
What NCT06425172 shows while recruiting
NCT06425172 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 4 conditions, with Plagiocephaly appearing as the primary indexed condition, and to 1 intervention - of which Cranial Remolding Orthosis is the first listed.
NCT06425172 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06425172 about?
NCT06425172 is a clinical study titled "Monitoring System for Cranial Orthoses". This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).
What is the current status of trial NCT06425172?
This trial is currently recruiting. The enrollment target is 12 participants. The study started on 2024-08-19. Estimated completion is 2026-06-01.
What conditions does trial NCT06425172 study?
This clinical trial studies the following conditions: Plagiocephaly, Brachycephaly, Deformational Plagiocephaly, Deformational Posterior Plagiocephaly.
What interventions are being tested in trial NCT06425172?
The interventions under investigation include: Cranial Remolding Orthosis (DEVICE).
Who is sponsoring clinical trial NCT06425172?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06425172 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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