MyoSure Hysteroscopic Tissue Removal System Registry Study

Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids.

Inclusion criteria

• Healthy female between 18 and 65 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 indicated for myomectomy or polypectomy
• Subject exhibits intrauterine polyps and/or submucous myomas which meet one of the following criteria. In cases of subjects with multiple intrauterine pathology, classification is based as follows:

• All polyps
• All Type 0, Type 1 or Type 2 myomas ≤ 6 cm in diameter
• Polyps plus Type 0, Type 1 or Type 2 myomas ≤6 cm in diameter

Exclusion criteria

• Subject is pregnant
• Subject has an Intrauterine Device (IUD) at the time of the procedure. A subject may be enrolled in the study if the IUD is removed prior to the treatment procedure
• Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin
• Active pelvic inflammatory disease or pelvic/vaginal infection
• Subject has a known or suspected coagulopathy or bleeding disorder
• Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)
• Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study