FERTI-LILY Safety Study

Safety Issues Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Safety Issues

• NCT number: NCT05529160
• Study type: Observational
• Source: Rosesta Medical BV
• Status: Completed
• Start date: July 29, 2022
• Completion date: September 21, 2022