Trial record 2 of 19 for:    Craniosynostosis

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This study has been withdrawn prior to enrollment.
(Study was withdrawn due to lack of resources.)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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014