Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT05153733
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years at time of study entry.
* T4 oral cavity tumor with mandible invasion, requiring segmental mandibulectomy.
* Reconstruction with free fibula flap not feasible because of any or a combination of the following reasons:
oCT angiography of the legs and/or the neck shows severe stenosis of the ves-sels.
* Previous medical history of severe atherosclerotic disease.
* General health condition necessitating a shorter operation time.
* Cases will be discussed in the multidisciplinary tumor board that they are eligible for composite resection but not eligible for free fibula flap.
* Written informed consent.
Exclusion Criteria:
* Patients who are eligible for free fibula flap.
* Pregnancy.
* General health condition does not allow surgery
* History of psychiatric disability judged by the investigator to potentially hamper compliance with the study protocol and follow-up schedule.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05153733
Study Brief:
Protocol Section:
NCT05153733