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

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

Inclusion Criteria:

• Sexually active women aged ≥18 years
• Able and willing to comply with all study procedures
• Able to provide written informed consent

Exclusion Criteria:

• Current pregnancy or within 6 weeks postpartum
• Symptomatic vaginal infection, lesion, or vulvovaginal discomfort at baseline
• Known allergy to any component of the study device
• Pelvic or vaginal surgery within the past 6 weeks
• Any medical or psychological condition that, in the investigator's opinion, may interfere with participation or safety