Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-03 @ 10:45 AM
Study NCT ID:
NCT02035332
Status:
COMPLETED
Last Update Posted:
2015-10-23
First Post:
2014-01-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Sponsor:
Minerva Surgical, Inc.
Organization:
Study Overview
Official Title:
A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Status:
COMPLETED
Status Verified Date:
2015-09
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 primary objective of this study is to evaluate the use of the Aurora Ablation System in reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events will be assessed along with an assessment of the reduction of uterine bleeding as measured by a pictorial blood loss assessment chart (PBLAC) or menstrual diary.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: