NL-OMON56871Not yet recruitingNot Applicable
The use of MRI-scans to assess velopharyngeal insufficiency in cleft palate patients - The use of MRI-scans to assess VPI
Amsterdam UMC0 sites30 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 2 to 64 (—)
Inclusion Criteria
- •- >4 years of age
- •- History of non-syndromic unilateral cleft lip and palate (UCLP)
- •- History of cleft palate repair (Von Langenbeck technique)
- •- No history of secondary palate surgery
- •- Hypernasality
- •- Informed consent
- •- Patient <12 years of age: informed consent required from parent(s)/legal
- •guardian(s)
- •- Patients 12-16 years of age: informed consent required from both patient and
- •parent(s)/legal guardian(s)
- •- Patient >16 years of age: informed consent required from patient
- •- Patient can be well instructed with regard to the MRI scan
Exclusion Criteria
- •- <4 years of age
- •- Syndromes
- •- No history of UCLP
- •- Primary cleft palate repair with other technique than Von Langenbeck
- •- History of secondary palate surgery
- •- No hypernasality
- •- No informed consent
- •- Non removable orthodontic device
- •- Patient cannot be well instructed with regard to the MRI scan
- •- Any exclusion criteria regarding the MRI scan
Investigators
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