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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT02829294
Eligibility Criteria:
Inclusion Criteria:
1. Males or non-pregnant females ≥ 40 years of age at enrollment;
2. Presence of excessive or impacted cerumen \[excessive or impacted cerumen is identified as causing partial (\> 50%) or complete occlusion of at least one ear canal when attempting to visualize the tympanic membrane\];
3. Willingness to participate in the study; or
4. Mental aptitude to provide verbal and/or written informed consent without the aid of another.
Exclusion Criteria:
1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study (has been accustomed to birth control and will continue it up to and including Visit 2);
2. Presence of a tympanostomy tube at any time during the previous 12 months;
3. Presence of a non-intact tympanic membrane (TM);
4. Presence of a known or suspected ear infection;
5. Presence of known or suspected mastoiditis;
6. Use of any ototopical drug or OTC product or earwax-removal product (with the exception of water or physiologic saline) during the preceding 3 days; or
7. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data (e.g. ear eczema or seborrhea).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02829294
Study Brief:
Protocol Section:
NCT02829294