ClinicalTrials.gg
RecruitingNCT06072495FENTIRMUpdated Jun 15, 2026

Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI

An interventional study of real time MRI in Velopharyngeal Insufficiency, Real Time MRI and Cleft Palate, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
7 Years to 12 Years
Sex
All
01

Study summary

Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).

02

Conditions studied

  • Velopharyngeal Insufficiency
  • Real Time MRI
  • Cleft Palate

Keywords

  • Velopharyngeal Insufficiency
  • real time MRI
  • Cleft palate
03

In context

Velopharyngeal Insufficiency

20 studies on the registry are indexed under Velopharyngeal Insufficiency; 9 are open to participants now.

This study's planned enrollment of 30 is above the median of 20 across 13 interventional studies indexed under Velopharyngeal Insufficiency.

Browse Velopharyngeal Insufficiency studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Refusal of the parents and/or the patient
  • With a 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    child with operated isolated labial cleft

    Other: real time MRI

  • Experimental
    child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy

    Other: real time MRI

  • Experimental
    child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy

    Other: real time MRI

  • Experimental
    child with isolated operated velopalatal cleft with normal anatomy and soft VPI

    Other: real time MRI

Interventions

  • Otherreal time MRI

    ubjects will be scanned in the supine position using ACHIEVA 3T TX DStream Philips® and a 33 channels head and neck coil. An elastic strap will be fixed to the forehead to limits movement during scan. Headset will be used to cancel the loud MRI noise and to communicate with the subjects

06

What researchers measure

Primary outcomes

  1. ratio between the diameter of pharynx at rest and during phonation.

    Time frame: day 1

  2. closure distance between the velar knee and the posterior pharyngeal wall

    Time frame: day 1

  3. distance between the velar knee and the posterior pharyngeal wall

    Time frame: day 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06072495
Responsible party
Sponsor
First posted
Oct 10, 2023
Start date
Nov 6, 2024
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Jun 15, 2026

Study contacts

Cica-Carole GBAGUIDI, MD
Contact
Gbaguidi.Cica-Carole@chu-amiens.fr
0322089050

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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