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

Study Overview

• Status: Completed
• Conditions: Vaginal Discharge; Postcoital Vaginal Changes
• Intervention / Treatment: Device: Livi Postcoital Tampon Device

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Mountain Lakes, New Jersey, United States, 07046
      • Garden State Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Livi Device Safety Evaluation; Participants will insert and remove the Livi device three times consecutively during a single clinic visit.	Device: Livi Postcoital Tampon Device; Single-use polyurethane foam pledget inserted via disposable applicator, designed to absorb semen post-intercourse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	after each study device removal, and up to 7 days following visit 1

Collaborators and Investigators

• Sponsor: Atlantic Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2026
• Primary Completion (Actual): February 9, 2026
• Study Completion (Actual): February 9, 2026

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: sexual intercourse; pelvic exam; tampon device; postcoital; vaginal mucosa; device safety
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Vaginal Diseases; Behavior; Sexual Behavior; Vaginal Discharge; Coitus
• Other Study ID Numbers: LIV-SAF-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No