Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

This study has been withdrawn prior to enrollment.
(Study was withdrawn due to lack of resources.)
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00769847
First received: October 7, 2008
Last updated: November 24, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention
Craniosynostosis
Procedure: Endoscopic strip craniectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

Resource links provided by NLM:


Further study details as provided by University of Utah:

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: September 2013
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sagittal synostosis
Male and female infants from 1-6 months of age with isolated, single suture sagittal craniosynostosis.
Procedure: Endoscopic strip craniectomy
Surgery

  Eligibility

Ages Eligible for Study:   1 Month to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Male and female infants, from 1 to 6 months of age with isolated, single-suture sagittal craniosynostosis.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769847

Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Faizi Siddiqu, MD University of Utah
  More Information

Publications:
Responsible Party: Faizi Siddiqi, M.D., Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT00769847     History of Changes
Other Study ID Numbers: 22034
Study First Received: October 7, 2008
Last Updated: November 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Endoscopic, craniosynostosis, sagittal, synostosis

Additional relevant MeSH terms:
Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Plagiocephaly
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 15, 2014