Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397885
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
Prospective On Market Patient-reported Outcomes for Milli
Sponsor:
Materna Medical
Organization:
Materna Medical
Study Overview
Official Title:
Prospective On Market Patient-reported Outcomes for Milli
Status:
RECRUITING
Status Verified Date:
2024-04
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:
POMPOM
Brief Summary:
To assess the effectiveness of the Milli device in achieving vaginal intercourse
Detailed Description:
The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion
This study is intended to provide data in support of the Milli Vaginal Dilator as a commercially available over-the-counter medical device
The Milli has been granted marketing authorization by the FDA under premarket notification K220035 for the following Indications for Use statement
The Milli Vaginal Dilator is a tool indicated for controlled dilation of the vagina It can be used for dilation for an examination by your doctor in preparation for a surgical procedure or to help relieve the symptoms of vaginismus condition that involves tightening of the vaginal muscles and related painful sex
This study is intended to provide data in support of the Milli Vaginal Dilator as a commercially available over-the-counter medical device
The Milli has been granted marketing authorization by the FDA under premarket notification K220035 for the following Indications for Use statement
The Milli Vaginal Dilator is a tool indicated for controlled dilation of the vagina It can be used for dilation for an examination by your doctor in preparation for a surgical procedure or to help relieve the symptoms of vaginismus condition that involves tightening of the vaginal muscles and related painful sex
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None