Status:
COMPLETED
ThermaChoice III Under Local Sedation in the Office Setting
Lead Sponsor:
Female Pelvic Medicine & Urogynecology Institute of Michigan
Collaborating Sponsors:
Ethicon, Inc.
Conditions:
Heavy Uterine Bleeding
Eligibility:
FEMALE
30-60 years
Phase:
NA
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 pati...
Eligibility Criteria
Inclusion
- Heavy uterine bleeding
Exclusion
- Uterine or cervical cancer
- Unable to tolerate office hysteroscopy
- Uterine fibroid tumors that distort endometrial cavity
- Uterine cavity greater than 12 cm
- Patients with hyperplasia or premalignant changes of the endometrium
- Active genital or urinary tract infections
- Intrauterine device
- Pregnant or want to become pregnant
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00420264
Start Date
November 1 2005
End Date
May 1 2009
Last Update
August 14 2013
Active Locations (1)
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1
Grand Valley Gynecologists, PC
Grand Rapids, Michigan, United States, 49506