HOME Study: Hysteroscopic Office Myomectomy Evaluation

Inclusion Criteria: * Healthy female between 18 and 55 years of age * Subject must be able to understand, read and sign the study specific informed consent forms after the nature of the study has been fully explained to her * Subject is a pre-menopausal or peri-menopausal female, either nulliparous or parous * Subject is experiencing AUB as confirmed by a symptom raw score of 23 or a calculated symptom score of 44.0 or higher on the Uterine Fibroid Scale and Health Related Quality of Life (UFS-QOL) * Subject is indicated for myomectomy or polypectomy for benign appearing pathology, based on a hysteroscopic exam and measured by saline infused sonogram assessment within 30 days of the planned index procedure * Subject exhibits intrauterine polyps and/or submucous myomas which, in the opinion of the treating physician, are compatible with office-based treatment (e.g. 15 minutes or less of cutting time) using the MyoSure device and meet at least one of the following criteria: * One or more polyps, with at least one of the polyps ≥ 1.5 cm and ≤ 3.0 cm diameter and having broad based attachment to the uterine wall. * Up to two Type 0 or Type 1 myomas with at least one of the myomas being ≥ 1.5 cm and none of the myomas being 3.0 cm diameter * If the first myoma is 3.0 cm, the second myoma must be ≤ 2.0 cm * Fundal myomas must be Type 0 * Polyps plus up to two Type 0 or Type I myomas with at least one of the myomas being ≥ 1.5cm and ≤ 3.0 cm * The subject demonstrates a negati…