Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:31 AM
Study NCT ID:
NCT07445958
Status:
COMPLETED
Last Update Posted:
2026-03-04
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device
Sponsor:
Atlantic Health System
Organization:
Study Overview
Official Title:
In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: