ThermaChoice III Under Local Sedation in the Office Setting
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation|
- Tolerability of Uterine Ablation in the office setting [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||May 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Device: Uterine Ablation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420264
|United States, Michigan|
|Grand Valley Gynecologists, PC|
|Grand Rapids, Michigan, United States, 49506|
|Principal Investigator:||Jason B Bennett, MD||Grand Valley Gynecologists, PC|