Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496080
Status:
TERMINATED
Last Update Posted:
2012-09-10
First Post:
2007-07-03
Brief Title:
Doppler-Guided Uterine Artery Occlusion DUAO Device for Fibroid Related Bleeding
Sponsor:
Ethicon Inc
Organization:
Ethicon Inc
Study Overview
Official Title:
A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial terminated early due to results from a similar study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUAO
Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion D-UAO for the reduction of fibroid associated bleeding
Detailed Description:
The GYNECARE GYNOCCLUDE D-UAO Instruments are single-use disposable instruments consisting of a GYNECARE GYNOCCLUDE Uterine Stabilizer a GYNECARE GYNOCCLUDEM Introducer Sheath a GYNECARE GYNOCCLUDE Doppler Clamp and a GYNECARE GYNOCCLUDE Coupler
Study Oversight
Has Oversight DMC:
None
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?:
None