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Procedure

Endoscopic Strip Craniectomy for Craniosynostosis

N/A
Recruiting
Led By David F Bauer, MD, MPH
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operatively (at 1 year of age)
Awards & highlights

Study Summary

This trial is investigating whether two different surgical treatments for craniosynostosis are equally effective. One treatment involves cutting the skull along the sides in addition to the back, and the other just involves cutting the back. The trial will compare outcomes including cranial expansion and aesthetic outcomes.

Who is the study for?
This trial is for babies under 6 months old with a condition called isolated, non-syndromic sagittal craniosynostosis. They must be patients at Texas Children's Hospital and able to have the surgery before reaching 6 months of age.Check my eligibility
What is being tested?
The study compares two surgical methods for treating sagittal craniosynostosis: endoscopic strip craniectomy (ESC) both with and without lateral osteotomies, followed by helmet therapy. It aims to see which method is better for skull shape and safety.See study design
What are the potential side effects?
Possible side effects from the surgeries may include swelling, infection risk at the incision site, bleeding, or reactions to anesthesia. Helmet therapy might cause skin irritation or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child has a skull condition and is under 6 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operatively (at recruitment) & post-operatively (at 1 year of age)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operatively (at recruitment) & post-operatively (at 1 year of age) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age
Secondary outcome measures
Aesthetic outcome
Amount of blood transfused
Estimated Blood loss
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Endoscopic strip craniectomy without the use of lateral osteotomiesExperimental Treatment1 Intervention
Patients will NOT have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.
Group II: Endoscopic strip craniectomy with the use of lateral osteotomiesActive Control1 Intervention
Patients will have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
999 Previous Clinical Trials
6,001,747 Total Patients Enrolled
David F Bauer, MD, MPHPrincipal InvestigatorBaylor College of Medicine

Media Library

Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04721769 — N/A
Sagittal Craniosynostosis Research Study Groups: Endoscopic strip craniectomy with the use of lateral osteotomies, Endoscopic strip craniectomy without the use of lateral osteotomies
Sagittal Craniosynostosis Clinical Trial 2023: Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy Highlights & Side Effects. Trial Name: NCT04721769 — N/A
Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04721769 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available to join the research protocol?

"The clinical trial is currently open for volunteers and has been listed on clinicialtrials.gov since December 18th 2020, with its last update occuring on January 19th 2022."

Answered by AI

How many participants are being observed in this experiment?

"Affirmative, clinicaltrials.gov displays evidence that this study is presently recruiting participants. It was originally posted on December 18th 2020 and most recently modified on January 19th 2022. The trial requires 150 patients to be enrolled from one site."

Answered by AI
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~52 spots leftby Dec 2025