Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation

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