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Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

NCT06238076 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-03-17

No results posted yet for this study

Summary

Fibula free flap is the gold standard for mandibular reconstruction. The shape of the fibula requires osteotomy that can be performed with a custom surgical guide. The use of surgical guide shorten surgical time, enhances the precision of the surgeon and reduces morbidity.

Since 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements, which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide.

The aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide.

Conditions

  • Mandibular Reconstruction

Interventions

DEVICE

Universal surgical device FIBUMAND

This device is made of biocompatible resin for type IIa medical devices with a 3D printer.

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Alice PREVOST, MD · University Hospital, Toulouse

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2026-03-31
Completion
2026-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06238076 on ClinicalTrials.gov