Clinical trial NCT05529160: FERTI-LILY Safety Study
Official title: A Prospective, 1-Arm, Open Label, Non-Randomized Study of the FERTI-LILY Conception Cup Device to Assess Label Comprehension, Device Usability and Safety in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Natural Conception
Label Comprehension
Device Usability
Safety Issues
Lead sponsor: Rosesta Medical BV
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who meet study eligibility criteria will be recruited from the patient population of the Principle Investigator's clinic.

Brief summary: The study is a prospective, 1-arm, open label, nonrandomized, single center study designed to evaluate label comprehension, device usability and safety of the FERTI·LILY Conception Cup. The primary safety endpoint will be an assessment of reported adverse events.

Subjects will be screened -10 (±3) days prior to the baseline visit. At baseline, 15-20 subjects meeting the inclusion/exclusion criteria will be provided with a FERTI·LILY Conception Cup device and instructions for using the device. Subjects will participate in a label comprehension protocol that includes the physician confirmation that they have adequate comprehension to enroll. If not, a screen failure form is completed.

Subjects will agree to try and use the device within 2 weeks of disposition therefore at baseline a two-week visit is scheduled. In the event they do not use the device within the two-week period the follow up visit can be rescheduled based on the visit window of +14 days. If it is not used within 4 weeks, the PI will have the subject return to the site to authorize another two-week period that will be captured as unscheduled follow up visit. The subject should complete the Device Experience Survey after each device use. The Device Experience Survey will be returned at this time, and adverse events will be assessed.


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.

Primary outcomes:
measure: Safety of Device
timeFrame: 6 weeks
Secondary outcomes:
measure: Label Comprehension Assessment Protocol
timeFrame: 6 weeks
measure: Device Usability
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Boca Raton Obstetrics and Gynecology
state: Florida
Study officials:
References: