Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

Exclusion Criteria

• •Known or suspected cancer, including breast, endometrial, and ovarian
• •Subject has Type 2 myoma
• •Contraindication and/or allergy to local anesthetic, or oral medications specified in the treatment protocol
• •Subject has a history of chronic narcotic use
• •Previous uterine artery embolization or other uterine artery occlusion procedure (Doppler or laparoscopic)
• •Subject with blood borne pathogens-HIV, hepatitis B, CJD, etc.
• •Subject plans to become pregnant within the study period
• •Subject has an 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 unmanaged endocrine disease
• •Subject has current or past, acute or chronic psychiatric disorder which, in the opinion of the Investigator, may preclude proper evaluation and follow-up
• •Subject has history of auto-immune, inflammatory, or connective tissue disease
• •Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)
• •Uncontrolled hypertension lasting two years or more
• •Use of any experimental drug or device within 30 days prior to the screening visit
• •The subject has a terminal illness that may prevent the completion of any follow-up assessments
• •Any employee or relative of an employee of the Sponsor company or any Investigator site employee or relative of employees working on the study
• •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