Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 11:56 AM
Study NCT ID:
NCT01979861
Status:
UNKNOWN
Last Update Posted:
2016-07-12
First Post:
2013-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
Sponsor:
Aegea Medical, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)
Detailed Description:
This is a single-arm, multi-center study with three years of follow-up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: