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

Atlantic Health System60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Vaginal Discharge Postcoital Vaginal Changes

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of Grade ≥2 vaginal mucosal trauma

Incidence of Grade ≥2 vaginal mucosal trauma assessed immediately after device removal via digital colposcopic examination. Mucosal trauma defined as: Grade 2 (Moderate): Abrasion \>5 mm or multiple foci totaling \>10 mm; pinpoint bleeding stopping spontaneously. Grade 3 (Severe): Laceration or bleeding requiring medical intervention.

Time frame: Immediate post-use (within 5 minutes of device removal)

Secondary Outcomes

Pain/discomfort during insertion/removal

Immediately after device insertion and removal, Numeric Rating Scale (0- no pain to 10- maximum pain) will be self-reported by patient.

Time frame: During Visit 1, immediately after device insertion/removal, and at 24-hours (+/- 6 hr)

Ease of use

Likert scale on ease of overall device use - Very Easy, Easy, Neither Easy Nor Difficult, Difficult, Very Difficult

Time frame: During Visit 1 immediately following third device insertion

Spotting or pain within 24 hours post-use

self-reported by subject on e-diary or telephone survey

Time frame: 24-hour (+/- 6hr) follow-up

Allergy and Hypersensitivity Responses

Mucosal changes consistent with allergy or hypersensitivity (eg edema, urticaria, swelling, itching) will be documented - this will be both reported subjectively by the patient, and objectively reported by the clinician using digital colposcopy examinations.

Time frame: after each study device removal, and up to 7 days following visit 1