ThermaChoice III Under Local Sedation in the Office Setting

N/ACompletedNCT00420264

Female Pelvic Medicine & Urogynecology Institute of Michigan21 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Heavy Uterine Bleeding

Interventions

Uterine AblationDEVICE

Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Grand Valley Gynecologists, PC

Grand Rapids, Michigan, United States

Outcomes

Primary Outcomes

Tolerability of Uterine Ablation in the office setting

Time frame: 30 days

Data from ClinicalTrials.gov

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