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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT06308016
Eligibility Criteria:
Inclusion Criteria:
Patients undergoing LT surgery with direct closure of the pharynx in case of:
* naïve laryngeal neoplasm (cT1-T3 and cT4a without extension to the esophagus or hypopharynx or oropharynx);
* recurrence of laryngeal neoplasm in a patient who has undergone previous surgical treatment (CO2 laser limited within the larynx or OPHL);
* recurrence of laryngeal neoplasm after RT or Ch-RT treatment;
* lack of functionality of the larynx induced by (Ch-)RT treatment;
* Availability of data according to the assessments that will have to be made, including a FU period of 2 months.
Exclusion Criteria:
* Use of flap, pedicled / free, on-lay / in-lay at the same time as LT surgery. Patients previously subjected to trans-oral surgery of the hypopharynx and/or oropharynx.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06308016
Study Brief:
Protocol Section:
NCT06308016