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NCT00769847 Clinical Trial

Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

Craniosynostosis Clinical Trial

Official title:
Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00769847
Other study ID # 22034
Secondary ID
Status Withdrawn
Phase N/A
First received October 7, 2008
Last updated May 29, 2015
Start date September 2008
Est. completion date September 2013

Study information
Verified date May 2015
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This is a prospective study to evaluate outcomes in patients undergoing endoscopic craniectomy for isolated, single-suture craniosynostosis.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2013
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Month to 6 Months
Eligibility Inclusion Criteria:

- Infants 1 to 6 months of age with isolated, single-suture craniosynostosis.

Exclusion Criteria:

- Multiple suture craniosynostosis and infants older than 6 months of age.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopic strip craniectomy
Surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

References & Publications (8)

HAAS LL. Roentgenological skull measurements and their diagnostic applications. Am J Roentgenol Radium Ther Nucl Med. 1952 Feb;67(2):197-209. — View Citation

Jimenez DF, Barone CM, McGee ME, Cartwright CC, Baker CL. Endoscopy-assisted wide-vertex craniectomy, barrel stave osteotomies, and postoperative helmet molding therapy in the management of sagittal suture craniosynostosis. J Neurosurg. 2004 May;100(5 Suppl Pediatrics):407-17. — View Citation

Jimenez DF, Barone CM. Endoscopic craniectomy for early surgical correction of sagittal craniosynostosis. J Neurosurg. 1998 Jan;88(1):77-81. — View Citation

Lane LC. Pioneer craniectomy for the relief of mental imbecility due to premature sutural closure and microcephalus. JAMA 18:49-50, 1892.

Lannelongue M. De la craniectomie dans la microcephalie. Compt Rend Seances Acad Sci 50:1382-1385, 1890.

Murad GJ, Clayman M, Seagle MB, White S, Perkins LA, Pincus DW. Endoscopic-assisted repair of craniosynostosis. Neurosurg Focus. 2005 Dec 15;19(6):E6. — View Citation

Obrien MO, Johnson M: Craniosynostosis, in Youmans JR (ed): Neurological Surgery, Philadelphia: WB Saunders, 1990, Vol 2, p 1328.

Panchal J, Marsh JL, Park TS, Kaufman B, Pilgram T, Huang SH. Sagittal craniosynostosis outcome assessment for two methods and timings of intervention. Plast Reconstr Surg. 1999 May;103(6):1574-84. — View Citation

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