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NCT04721769 · ClinicalTrials.gov registry record · NA
Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis
A NA study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT04721769: Clinical Trial NA study, sponsored by Baylor College of Medicine.
NCT04721769 is a NA study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04721769, a NA study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
* Endoscopic strip craniectomy (ESC) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce perioperative morbidity when compared to more invasive procedures such as cranial vault remodeling. ESC is frequently performed with or without the use of lateral osteotomies with technical selection being largely based on surgeon preference. * Previous studies have shown that there are no statistically significant differences in cranial expansion or complications between the two procedure variants; however, these studies are retrospective in nature and do not account for aesthetic outcomes. * The purpose of this study is to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis. In addition, we seek to investigate if there are any observable changes in perioperative morbidity between the two procedures.
Primary Outcome
The cephalic index is the ratio of maximal head width and length. Patients enrolled in the trial will undergo pre-operative and post-operative measurement of their cephalic index using the STARscanner© (Orthomerica products Inc.). Patients will undergo measurement at recruitment and at 1 year of age.
Interventions
- PROCEDURE Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy
- PROCEDURE Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2025-05-01 |
| Phase | NA |
Why NCT04721769 stopped before completion
NCT04721769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy is the first listed.
NCT04721769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04721769 about?
NCT04721769 is a clinical study titled "Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis". * Endoscopic strip craniectomy (ESC) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce perioperative morbidity when compared to more invasive procedures such as...
What is the current status of trial NCT04721769?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2020-12-18. Estimated completion is 2025-05-01.
What interventions are being tested in trial NCT04721769?
The interventions under investigation include: Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy (PROCEDURE), Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy (PROCEDURE).
Who is sponsoring clinical trial NCT04721769?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04721769's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 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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