NCT07445958

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Atlantic Health System · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Vaginal Discharge
• Postcoital Vaginal Changes

Interventions

Type	Name	Description
DEVICE	Livi Postcoital Tampon Device	Single-use polyurethane foam pledget inserted via disposable applicator, designed to absorb semen post-intercourse.

Timeline

• Start date: 2026-01-28
• Primary completion: 2026-02-09
• Completion: 2026-02-09
• First posted: 2026-03-03
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study