Evaluation of an Universal Surgical Device for Mandibular Reconstruction.
NCT ID: NCT06238076
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
19 participants
INTERVENTIONAL
2024-03-28
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Group experimental
The patients included in the study and admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction will benefit from a surgery assisted with the universal surgical device FIBUMAND.
Universal surgical device FIBUMAND
This device is made of biocompatible resin for type IIa medical devices with a 3D printer.
Interventions
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Universal surgical device FIBUMAND
This device is made of biocompatible resin for type IIa medical devices with a 3D printer.
Eligibility Criteria
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Inclusion Criteria
* Patients insured under the French social security system
* Free and informed consent
Exclusion Criteria
* Legally incompetent
* Inclusion in another protocol of research , involving mandibular reconstruction
* Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Alice PREVOST, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC31/17/0347
Identifier Type: -
Identifier Source: org_study_id
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