Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058096) titled 'Analysis of craniosynostosis by geometric analysis' on Aug. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Keio University
Condition:
Condition - craniosynostosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Craniosynostosis is a rare disease in which the cranial suture closes prematurely, either congenitally or acquired. Premature closure of the suture results in insufficient cranial expansion in response to rapid brain growth during the first six months of life, leading to increased intracranial pressure and skull deformity, which adversely affects normal brain development. Although deformities of typical cases can be identified, there are many cases where this is not the case, and these deformities are defined on the basis of morphologically objective image data.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 1
days-old
=
Gender - Male and Female
Key inclusion criteria - Number of patients diagnosed and treated for craniosynostosis, as well as normal patients who presented for trauma and had a head CT scan.
Key exclusion criteria - Cases in which the individual or a surrogate has indicated his/her refusal when consenting to participate in the study (as is the patient's right).
Other cases in which the responsible person at the respective institution considers the subject to be unsuitable for the study (insufficient data for analysis due to rough CT).
Target Size - 250
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2021 Year 11 Month 05 Day
Date of IRB - 2022 Year 01 Month 07 Day
Anticipated trial start date - 2022 Year 01 Month 08 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066397
Disclaimer: Curated by HT Syndication.
