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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 is a NA study that has completed, run by Atlantic Health System. The registered enrollment target is 60 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07445958
The ClinicalTrials.gov registry entry for NCT07445958 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atlantic Health System, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Livi Postcoital Tampon Device is the first listed.
NCT07445958 reports 0 study locations.
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.
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