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