HOME Study: Hysteroscopic Office Myomectomy Evaluation

Approximately one hundred subjects will be enrolled in a randomized, comparative setting study conducted at 10-15 investigational sites. Sixty subjects will be randomized to undergo treatment in an office setting, and 40 subjects will be randomized to undergo treatment in a hospital or ambulatory surgical center (ASC) setting. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids. Saline infused sonohysterogram images (SIS) obtained at three months post treatment will be compared to pre-treatment images, to determine the percent reduction in target pathology volume. Additionally, subject self-reported pain scores (as rated on an 11 point scale) will compare pain occurring during the treatment procedure to the average pain level experienced during a PAP smear. Economic data will be collected and compared between the two treatment settings.

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