ThermaChoice III Under Local Sedation in the Office Setting

Female Pelvic Medicine & Urogynecology Institute of Michigan

Status: Completed

Conditions: Heavy Uterine Bleeding

Treatments: Device: Uterine Ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00420264

ThermaChoice III

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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