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

NCT07445958 | Completed FDA Device

• 1 other identifier: LIV-SAF-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tampon device; postcoital; vaginal mucosa; device safety; sexual intercourse; pelvic exam

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (4)

• Pain/discomfort during insertion/removal

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

• Ease of use

  During Visit 1 immediately following third device insertion

• Spotting or pain within 24 hours post-use

  24-hour (+/- 6hr) follow-up

• Allergy and Hypersensitivity Responses

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

Study Arms (1)

Livi Device Safety Evaluation

EXPERIMENTAL

Participants will insert and remove the Livi device three times consecutively during a single clinic visit.

Device: Livi Postcoital Tampon Device

Interventions

Livi Postcoital Tampon Device DEVICE

Single-use polyurethane foam pledget inserted via disposable applicator, designed to absorb semen post-intercourse.

Livi Device Safety Evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Garden State Urology

Mountain Lakes, New Jersey, 07046, United States

Location

MeSH Terms

Conditions

Vaginal Discharge; Coitus

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: March 3, 2026
• Study Start: January 28, 2026
• Primary Completion: February 9, 2026
• Study Completion: February 9, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)