Using a universal surgical device for jaw reconstruction
Official title: Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.
Run by University Hospital, Toulouse · NCT06238076 · Data updated 2026-11-12
This study tests a new surgical device to see if it can make jaw reconstruction easier and safer for patients needing this type of surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 19 (estimated) |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Status | Recruiting |
| Started | March 28, 2024 |
| Main results expected | March 2026 |
| Study ends | May 2026 |
| Registry record updated | March 17, 2025 |
| Trial ID | NCT06238076 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients admitted for mandibular fibula free flap reconstruction who are insured under the French social security system.
✕Probably not a fit
Patients requiring lateral mandibular reconstruction without symphysis reconstruction or those who are pregnant or breastfeeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a universal surgical device designed for mandibular reconstruction using a fibula free flap. The device aims to enhance surgical precision, reduce operation time, and minimize patient morbidity by providing a custom surgical guide. The research will assess whether this universal guide can successfully facilitate the reconstruction process compared to traditional methods. Participants will be patients admitted for mandibular reconstruction who meet specific eligibility criteria.
Why it matters
Potential benefit: If successful, this approach could lead to more efficient and safer surgical procedures for patients requiring mandibular reconstruction.
How similar studies have gone: While custom surgical guides have been used successfully in the past, this study explores a novel universal guide approach, which has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction including a symphysial bone fragment * Patients insured under the French social security system * Free and informed consent Exclusion Criteria: * Lateral mandibular reconstruction without symphysis reconstruction * Legally incompetent * Inclusion in another protocol of research , involving mandibular reconstruction * Pregnant or breastfeeding women
Where it's running
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CHU Toulouse
Toulouse, France Recruiting
Study contacts
- Principal investigator: Alice PREVOST, MD — University Hospital, Toulouse
- Study coordinator: Alice PREVOST, MD
- Email: prevost.a@chu-toulouse.fr
- Phone: +335 61 77 95 43
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.