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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02634957
Eligibility Criteria:
Inclusion Criteria:
1. Patients with benign mid membranous vocal fold lesions such as the following:
1. Polyps
2. Cysts
3. Sub-epithelial fibrous mass
2. Undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds.
3. Age 18 and older
Exclusion Criteria:
Patients with any of the following will be excluded from the study:
1. Reinke's edema
2. Active smokers
3. Ligamentous mid membranous vocal fold lesions
4. RRP (Recurrent Respiratory Papillomatosis)
5. Dysplasia
6. CIS (Carcinoma-in-situ)
7. SCC (squamous cell carcinoma)
8. Extent of surgery exceeds what is mentioned in the inclusion criteria (e.g., CO2 laser, balloon dilatation, vocal fold augmentation in addition to phonomicrosurgery)
9. Previous vocal fold surgery
10. Systemic steroids
11. History of systemic illness that could affect wound healing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02634957
Study Brief:
Protocol Section:
NCT02634957