Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420264
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2007-01-10
Brief Title:
ThermaChoice III Under Local Sedation in the Office Setting
Sponsor:
Female Pelvic Medicine Urogynecology Institute of Michigan
Organization:
Female Pelvic Medicine Urogynecology Institute of Michigan
Study Overview
Official Title:
Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation
Status:
COMPLETED
Status Verified Date:
2013-08
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:
Investigational study to determine if an endometrial ablation for heavy uterine bleeding can be tolerated in the office setting without the use of intravenous medication
Detailed Description:
A safe and effective treatment called endometrial ablation has been used in a hospital setting under general anesthesia for the treatment of heavy uterine bleeding This study will evaluate if patients would tolerate the same procedure in an office setting using local anesthetics and common pain medication This study will include twenty patients
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