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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT02756351
Eligibility Criteria:
Inclusion Criteria:
1. Legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF).
2. Subject is between 18 and 65 years of age.
3. Subjects that have intact, wound free and scar free skin at the Nasal Prong target site.
4. Subject that have intact, irritation-free nasal mucus membrane.
Exclusion Criteria:
1. Pregnant or nursing women.
2. Subjects who are active smokers or using snuff.
3. Subjects currently suffering from a common cold, sinusitis, allergies or sleep apnea.
4. Subjects suffering from and/or subjects that have experienced nosebleed within 1 month prior to entering the study.
5. Subjects using and/or subjects that have used oral or topical antibiotics within 2 weeks prior to entering the study.
6. Subjects using and/or subjects that have used oral or topical anti-inflammatory drugs within 1 week prior to entering the study.
7. Subjects participating in any other clinical study.
8. Subjects diagnosed with any type of skin infection (bacterial, viral or fungal) or inflammatory skin disease including psoriasis, eczema or severe acne
9. Subjects diagnosed with any type disease affecting mucus membranes.
10. Subjects suffering from any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment.
11. Subjects who have a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the Nasal Prong target site
12. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02756351
Study Brief:
Protocol Section:
NCT02756351