NCT00420264CompletedNot Applicable
Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation
Female Pelvic Medicine & Urogynecology Institute of Michigan2 sites in 1 country21 target enrollmentStarted: November 1, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Tolerability of Uterine Ablation in the office setting
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Heavy uterine bleeding
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Tolerability of Uterine Ablation in the office setting
Time Frame: 30 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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