Vaginal DischargeNCT07445958
In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device
A study testing Livi Postcoital Tampon Device in people with Vaginal Discharge and Postcoital Vaginal Changes, run by Atlantic Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Discharge, Postcoital Vaginal Changes
- What is being tested?
- Livi Postcoital Tampon Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to 9 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sexually active women aged ≥18 years
- Able and willing to comply with all study procedures
- Able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Garden State Urology
Mountain Lakes, New Jersey, 07046
About this study
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?
Read more
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
- Being tested
- Livi Postcoital Tampon Device
- Keywords
- tampon device, postcoital, vaginal mucosa, device safety, sexual intercourse, pelvic exam
- Medical subject headings
- Vaginal Discharge, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Livi Postcoital Tampon DeviceDevice
Single-use polyurethane foam pledget inserted via disposable applicator, designed to absorb semen post-intercourse.
| Study group | Role | What they receive |
|---|---|---|
| Livi Device Safety Evaluation | Experimental | Participants will insert and remove the Livi device three times consecutively during a single clinic visit. Receives: Device: Livi Postcoital Tampon Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate post-use (within 5 minutes of device removal)
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: after each study device removal, and up to 7 days following visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start28 Jan 2026
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DischargeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Ingber, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445958
- Sponsor's protocol ID
- LIV-SAF-001
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device
- ClinicalTrials.gov ID
- NCT07445958
- Acronym / sponsor ID
- LIV-SAF-001
- Conditions
- Vaginal Discharge, Postcoital Vaginal Changes
- Keywords
- tampon device, postcoital, vaginal mucosa, device safety, sexual intercourse, pelvic exam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Livi Device Safety Evaluation | Experimental | Device: Livi Postcoital Tampon DeviceParticipants will insert and remove the Livi device three times consecutively during a single clinic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sexually active women aged ≥18 years
- Able and willing to comply with all study procedures
- Able to provide written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Livi Postcoital Tampon DeviceSingle-use polyurethane foam pledget inserted via disposable applicator, designed to absorb semen post-intercourse. | Device | Livi Device Safety Evaluation |
Primary outcome
Incidence of Grade ≥2 vaginal mucosal trauma
Time frame: Immediate post-use (within 5 minutes of device removal)
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.
4 secondary outcomes
Pain/discomfort during insertion/removal
Time frame: During Visit 1, immediately after device insertion/removal, and at 24-hours (+/- 6 hr)
Ease of use
Time frame: During Visit 1 immediately following third device insertion
Spotting or pain within 24 hours post-use
Time frame: 24-hour (+/- 6hr) follow-up
Allergy and Hypersensitivity Responses
Time frame: after each study device removal, and up to 7 days following visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Livi Postcoital Tampon Device in people with Vaginal Discharge and Postcoital Vaginal Changes, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥2 vaginal mucosal trauma (time frame: Immediate post-use (within 5 minutes of device removal)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.