FERTI-LILY Safety Study

Completed

• Conditions: Label Comprehension; Natural Conception; Device Usability; Safety Issues
• Interventions: Device: FERTI LILY Conception Cup

• Registration Number: NCT05529160
• Lead Sponsor: Rosesta Medical BV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-29
• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-21
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Population	FERTI LILY Conception Cup	Up to 20 subjects will be recruited from the patient population at the Principal Investigator's clinic. Subject recruitment will end once 15 evaluable subjects have completed the study.

Primary Outcome Measures

Name	Time	Method
Safety of Device	6 weeks	Occurrence of device-related adverse events.

Secondary Outcome Measures

Name	Time	Method
Label Comprehension Assessment Protocol	6 weeks	PI using questions and answers to assess comprehension and confirms subject can specify location and use of cup in vaginal model.
Device Usability	6 weeks	After use reported by subject: ease of use, user compliance, overall satisfaction, comfort, size of device.

Trial Locations

Locations (1)

Boca Raton Obstetrics and Gynecology; 🇺🇸 Boca Raton, Florida, United States