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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 is a NA study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04721769
The ClinicalTrials.gov registry entry for NCT04721769 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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