In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device

The goal of this clinical trial is to learn if the Livi postcoital tampon device is safe for repetitive use in sexually active women aged 18 years and older. The main question it aims to answer is: Does using the Livi device three times in a row cause any visible vaginal mucosal trauma? How much pain or discomfort do participants experience during insertion and removal? Researchers will not compare the Livi device to another product because this is a single-arm safety study. Participants will: * Insert and remove the Livi device three times consecutively during one clinic visit * Undergo a baseline speculum exam and digital colposcopy exams after each device removal to check vaginal tissue * Complete a 24-hour follow-up via e-diary or phone call to report pain, spotting, or other symptoms * Report any unsolicited symptoms for 7 days after use

NCT Number	NCT07445958
Lead Sponsor	Atlantic Health System
Conditions	Vaginal Discharge, Postcoital Vaginal Changes
Enrollment	60 participants
Start Date	2026-01-28
Primary Completion	2026-02-09 (estimated)
Study Completion	2026-02-09 (estimated)
Updated on ClinicalTrials.gov	2026-03-04