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:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT03864757
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients between 18 and 80 years
* Diagnosed with permanent UVFP and insufficient glottal closure and planned type I thyroplasty with conventional implant
* Ability to co-operate with the investigator and to comply with the requirements of the entire study
Exclusion Criteria:
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the clinical investigation may influence the result of the clinical investigation, or the participant's ability to participate in the clinical investigation
* Scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation
* Had medialization thyroplasty before
* Had injection medialization laryngoplasty in the past two years.
* Presence of structural vocal fold lesions such as polyp or nodules
* Status post total cordectomy
* Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
* Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
* Severe coagulopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03864757
Study Brief:
Protocol Section:
NCT03864757