Velopharyngeal InsufficiencyFENTIRMNCT06072495
Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI
A study testing real time MRI in people with Velopharyngeal Insufficiency and Real Time MRI, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Velopharyngeal Insufficiency, Real Time MRI, Cleft Palate
- What is being tested?
- real time MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
Cica-Carole Gbaguidi, MD, 0322089050, Gbaguidi.Cica-Carole@chu-amiens.fr
Sylvie TESTELIN, Pr
About this study
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).
- Conditions
- Velopharyngeal Insufficiency, Real Time MRI, Cleft Palate
- Being tested
- real time MRI
- Keywords
- Velopharyngeal Insufficiency, real time MRI, Cleft palate
- Medical subject headings
- Velopharyngeal Insufficiency, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real time MRIOther
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
| Study group | Role | What they receive |
|---|---|---|
| child with operated isolated labial cleft | Experimental | Not described Receives: Other: real time MRI |
| child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy | Experimental | Not described Receives: Other: real time MRI |
| child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy | Experimental | Not described Receives: Other: real time MRI |
| child with isolated operated velopalatal cleft with normal anatomy and soft VPI | Experimental | Not described Receives: Other: real time MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio between the diameter of pharynx at rest and during phonation.
Measured: day 1
closure distance between the velar knee and the posterior pharyngeal wall
Measured: day 1
distance between the velar knee and the posterior pharyngeal wall
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start6 Nov 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Velopharyngeal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072495
- Sponsor's protocol ID
- PI2021_843_0208
- Acronym
- FENTIRM
- Status last verified
- Jun 2026
- First submitted
- 3 Oct 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI
- ClinicalTrials.gov ID
- NCT06072495
- Acronym / sponsor ID
- FENTIRM / PI2021_843_0208
- Conditions
- Velopharyngeal Insufficiency, Real Time MRI, Cleft Palate
- Keywords
- Velopharyngeal Insufficiency, real time MRI, Cleft palate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| child with operated isolated labial cleft | Experimental | Other: real time MRI |
| child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy | Experimental | Other: real time MRI |
| child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy | Experimental | Other: real time MRI |
| child with isolated operated velopalatal cleft with normal anatomy and soft VPI | Experimental | Other: real time MRI |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real time MRIubjects 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 | Other | child with isolated operated velopalatal cleft with normal anatomy and soft VPI, child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy, child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy, child with operated isolated labial cleft |
Primary outcome
ratio between the diameter of pharynx at rest and during phonation.
Time frame: day 1
closure distance between the velar knee and the posterior pharyngeal wall
Time frame: day 1
distance between the velar knee and the posterior pharyngeal wall
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Velopharyngeal Insufficiency
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Donor Site Morbidity and Buccinator Muscle Integrity After Buccinator Myomucosal Flap Surgery in Patients With Velopharyngeal Incompetence
Donor Site, Morbidity
Not yet recruitingObservational study
Effect of Velopharyngeal Gap Size on Laryngeal Morphology and Vocal Function in Children With VPI
Velopharyngeal Insufficiency
Recruiting
Expiratory Muscle Strength Training for Hypernasal Speech in Children
Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate
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Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
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Not yet recruiting
MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real time MRI in people with Velopharyngeal Insufficiency and Real Time MRI, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cica-Carole GBAGUIDI, MD (0322089050, Gbaguidi.Cica-Carole@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ratio between the diameter of pharynx at rest and during phonation. (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.