Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT06072495
Eligibility Criteria:
Inclusion Criteria:
* Children aged 7 to 12 years with Isolated cleft lip
* isolated velopalatal cleft
* Without a diagnosis of syndromic cleft or Pierre Robin sequence
* French speaking, and French is the native language
* Operated with a cheiloplasty (for cleft lip) or an intravelar Veloplasty (according to Sommerlad) at the Amiens University Hospital
* Whose follow-up is done at the Amiens University Hospital
Exclusion Criteria:
* Refusal of the parents and/or the patient
* With a contraindication to MRI
* Whose follow-up was initiated in another center and/or whose surgery was performed in another center
* Whose surgical schedule has not been followed
* Patient with severe neurological or neuropsychiatric disorders or Severe speech and language delay not related to the cleft anatomy
* Patients treated with fixed, non-removable orthodontic treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT06072495
Study Brief:
Protocol Section:
NCT06072495