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

Part of paid clinical trials in Mountain Lakes, New Jersey.

Sponsor
Atlantic Health System
Study ID
NCT07445958
Status
Completed

Conditions

  • Postcoital Vaginal Changes
  • Vaginal Discharge

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 28, 2026
Status verified
Mar 2026
Primary completion
Feb 9, 2026
Completion
Feb 9, 2026

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Livi Device Safety Evaluation
    Participants will insert and remove the Livi device three times consecutively during a single clinic visit.

Primary Outcome Measure

Incidence of Grade ≥2 vaginal mucosal trauma [ Time Frame: Immediate post-use (within 5 minutes of device removal) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Garden State UrologyMountain LakesNew Jersey07046-

Find similar trials in Mountain Lakes, NJ

By research site
Garden State Urology· Mountain Lakes, NJ

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