Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07445958
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
Study:
NCT07445958
Study Brief:
Protocol Section:
NCT07445958