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NCT06831513 · ClinicalTrials.gov registry record · NA
Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT06831513: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT06831513 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06831513, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study 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
Primary Outcome
Skull measurement are taken at every appointment the participant attends. At the end of treatment, the measurements will be compared to the participants starting measurements. Measurements can be taken by hand, using a tape measure and calipers. Or using an FDA approved scanner -- OMEGA Scanner 3D or Orthomerica STARscanner. * Cranial Vault Asymmetry (CVA) measures the difference between the lengths of two diagonals on the top of the skull. These diagonals are measured at a 30-degree angle from
Interventions
- DEVICE Serkel 3D CRO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-05-24 |
| Est. Completion | 2024-04-05 |
| Phase | NA |
What the finished NCT06831513 record still lists
NCT06831513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Serkel 3D CRO is the first listed.
NCT06831513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06831513 about?
NCT06831513 is a clinical study titled "Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly". 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
What is the current status of trial NCT06831513?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2022-05-24. Estimated completion is 2024-04-05.
What interventions are being tested in trial NCT06831513?
The interventions under investigation include: Serkel 3D CRO (DEVICE).
Who is sponsoring clinical trial NCT06831513?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06831513's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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