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 negative pregnancy test within 48 hours prior to the planned index procedure
* The subject must document a score of 5 or lower on the Pap Smear and Blood Draw scales of the Pain Tolerance Survey

Exclusion Criteria:

* Subject has known or suspected cancer, including breast, endometrial, and ovarian
* Contraindication and/or allergy to local anesthetic, or oral medications specified in the treatment protocol
* The subject has a history of chronic narcotic use
* Previous uterine artery embolization or other uterine artery occlusion procedure (Doppler or laparoscopic)
* Subject has blood borne pathogens-HIV, hepatitis B, CJD, etc.
* 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 a 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
* Subject has one of the following:

  * Type II submucosal myoma
  * Type O or Type I submucosal myoma \> 3.0 cm
  * Fundal Type I myoma
  * Highly vascularized myoma as determined by SIS or hysteroscopic examination