Laparoscopic Radiofrequency Ablation of Symptomatic Uterine Fibroids (Halt Lap RFA)

Inclusion Criteria:

• Are premenopausal and ≥ 25 years old
• Have symptomatic uterine fibroids
• Have a uterine gestational size ≤14 weeks as determined by pelvic exam
• Have ≤ 6 (six) treatable fibroids in whom no single fibroid exceeds 7 cm in any diameter as measured by ultrasound or magnetic resonance imaging (MRI). Only Fibroids greater than 1cm in diameter should be treated in this study
• Have a total uterine fibroid volume that does not exceed 300cc on ultrasound or contrast-enhanced MRI evaluation
• Have clinical menorrhagia as indicated by menstrual blood loss of ≥160 mL to 500 ml during one baseline cycle or two baseline cycles within three months prior to treatment
• Have a history of at least 3 months of menorrhagia within the last six months
• Desire uterine preservation
• Do not desire current or future childbearing
• Have a normal coagulation profile (INR, Platelets, PT, and PTT)
• Have had a normal Pap smear within the past 12 months
• Are practicing non-hormonal or stable hormonal contraception
• If the woman is not currently taking any hormonal contraceptives, has been off all hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through the 12 months of follow-up OR

• If the woman is currently taking hormonal contraceptives, has taken hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through 12 months of follow up.**

  **Note: Hormonal contraceptive use must be terminated 30 days prior to treatment but should be resumed post-operatively within 60 days post treatment as instructed by the Investigator.

• Are willing and able to comply with all study tests, procedures, and assessment tools
• Are willing and able to return for all required follow up visits following study enrollment
• Must pass a pre-operative health exam (ASA I-III)
• Are capable of providing informed consent

Exclusion Criteria:

• Have contraindications for laparoscopic surgery and/or general anesthesia. (Contraindications include anemia, defined as a hemoglobin level under 10 or hematocrit level less than 30.)
• Have had prior pelvic surgery (with the exception of C-section, tubal ligation, or diagnostic laparoscopy), or are known to have significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
• Have previously undergone endometrial ablation, uterine artery embolization, or uterine artery ligation, or any other uterine-preserving technique for reduction of menstrual bleeding (with the exception of hysteroscopic myomectomy > 1 year ago)
• Patients requiring elective concomitant procedures
• Have contraindications for magnetic resonance imaging (MRI)
• Desire current or future childbearing
• Are pregnant or lactating
• Have taken any GnRh agonist within three months prior to the screening procedures
• Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed one month prior to treatment
• Have dysfunctional uterine bleeding or bleeding between periods
• Have chronic pelvic pain not due to uterine fibroids
• Have known or suspected endometriosis
• Have known or suspected adenomyosis based on Ultrasound or MRI findings
• Have active or history of pelvic inflammatory disease
• Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years
• Have had pelvic radiation
• Have a non-uterine pelvic mass
• Have a cervical myoma
• Have one or more pedunculated subserosal fibroids or "type zero" (completely intracavitary) submucous fibroids
• Are peri-menopausal (defined as women 40 years of age or older with FSH level of ≥ 25 IU) or menopausal
• Are unable to give informed consent
• In the medical judgment of the investigator should not participate in the study