• Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AE) [ Time Frame: up to 4 weeks post procedure. ] [ Designated as safety issue: Yes ]
  
• Technical success and procedure feasibility [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
  

• Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) completed by the patient [ Time Frame: prior to discharge from hospital. ] [ Designated as safety issue: No ]
  
• Time (in days) to return to normal activity [ Time Frame: 4 weeks post procedure ] [ Designated as safety issue: No ]
  
• Average duration of post operative hospital stay [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
  
• Evaluation of length of an average procedure [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
  
• Physician's satisfaction from the ease and convenience of the procedure [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
  

Currently there are no optimal methods for treating symptomatic uterine fibroids. Existing therapeutic options are conservative (medications), invasive (e.g., hysterectomy, surgical myomectomy), or minimally invasive (uterine artery embolization, or myolysis).

Fibroid ablation using cryogenic energy, known as Cryoablation, offers a potential alternative method of fibroid treatment. Cryotherapy is a well-established technique for the treatment of various benign and malignant conditions. Cryoablation has been described for the treatment of prostate cancer, renal cell carcinoma, liver tumors and benign and malignant breast tumors.

Galil Medical's proposed feasibility study is looking to examine the technical success, safety and feasibility of a hysteroscopic approach for the treatment of symptomatic fibroids. This technique involves the insertion and placement of Galil Medical's 17-gauge cryoablation needle(s)guided by a hysteroscopic device. Ultrasound provides real-time monitoring of the needle insertion, placement and iceball propagation during the cryoablation procedure.

This treatment offers the patient to preserve her uterus by a minimally invasive procedure. The type of the fibroids intended for treatment (Type II submucous myomas)are often very difficult to completely and safely remove hysteroscopically and are often treated through an open or laparoscopic procedure. A hysteroscopic procedure does not involve intraperitoneal intervention and is therefore expected to be associated with less intra-operative and post-operative complications.

The recovery from hysteroscopic cryoablation is expected to be fast with only minimal self resolving discomfort. The patient should be able to return to her normal activity within 24-48 hours.

Inclusion Criteria:

• Primary complaint is excessive bleeding
• Subject is able to understand and give informed consent for participation in the study
• Pre-menopausal woman between the ages of 30 and 50 (inclusive)
• Has completed childbearing and not contemplating future fertility
• Has symptomatic uterine fibroids

• Fibroids type, size, location and number

  • 1 submucosal fibroid
  • Type I and Type II fibroids
  • 2 to 4cm
• Using contraception to prevent pregnancy

Exclusion Criteria:

• Any evidence of known or suspected infection or pre-malignancy/malignancy
• Desire for future child bearing

• Fibroids

  • Size > 4cm
  • 2 or more submucosal fibroids
  • Fibroid distance from the serosa is less than 1 cm