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New surgery aims to help kids with rare skull condition breathe easier

NCT ID NCT01022008

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a surgical technique called osteodistraction to improve breathing in 14 children with faciocraniosynostosis, a condition where skull bones fuse too early. The surgery uses devices to gradually separate and reshape the skull and face. The main goal was to see if it could improve respiratory function and reduce sleep apnea.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Osteodistraction device
What this could lead to
If successful, this could lead to a surgical technique that significantly improves breathing and reduces sleep apnea in children with faciocraniosynostosis.
What could go wrong
This is a small, early-stage study with only 14 participants, so results may not apply to everyone. The surgery carries risks like infection and may not fully correct breathing problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Sep 2009

Finished

Sep 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age under 18 years * faciocraniosynostosis * surgery indication to craniofacial osteotomies * informed consent * social security Exclusion Criteria: * no possibilities of follow-up during one year post-surgery * history of radiotherapy * acquired or hereditary immunodeficiency syndromes * mental retardation * bone conditions could not support distractors

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Faciocraniosynostoses

Contacts and locations

Locations

  • Hopital Necker

    Paris, 75015, France