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NCT07445958 · ClinicalTrials.gov registry record · NA
In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device
A NA study, sponsored by Atlantic Health System.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT07445958: Completed NA study, sponsored by Atlantic Health System.
NCT07445958 is a NA study that has completed, run by Atlantic Health System. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07445958, a NA study, has completed, sponsored by Atlantic Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- DEVICE Livi Postcoital Tampon Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-01-28 |
| Est. Completion | 2026-02-09 |
| Phase | NA |
What the finished NCT07445958 record still lists
NCT07445958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Livi Postcoital Tampon Device is the first listed.
NCT07445958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07445958 about?
NCT07445958 is a clinical study titled "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 pa...
What is the current status of trial NCT07445958?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2026-01-28. Estimated completion is 2026-02-09.
What interventions are being tested in trial NCT07445958?
The interventions under investigation include: Livi Postcoital Tampon Device (DEVICE).
Who is sponsoring clinical trial NCT07445958?
This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07445958's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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