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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05529160
Eligibility Criteria:
Inclusion Criteria:
* Subject is a female volunteer, age ≥ 18 years.
* Subject is willing and able to provide written informed consent for study participation.
* Subject agrees to use the FCC device as directed.
* Subject agrees to complete all study-related assessments.
* Subject agrees to try to use the cup within two weeks of disposition.
* PI confirms that the subject had the adequate label comprehension to enroll in the study.
Exclusion Criteria:
* Subject has a medical condition or other factor that, in the opinion of the investigator, would contraindicate participation in the study.
* Subject has active bacterial vaginosis infection or vaginismus.
* Subject has an abnormal clinically significant Pap Smear diagnosis.
* Subject has a history of endometriosis.
* Subject has any contraindications with the Instructions for Use.
* Subject has an allergy to silicone.
* Subject is pregnant or lactating.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05529160
Study Brief:
Protocol Section:
NCT05529160