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

25 Years
Open (Enrolling)
Uterine Fibroids, Uterine Myomas

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Trial Information

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

In this single-arm study, subjects who have symptomatic uterine fibroids will have
laparoscopic surgery in which intra-abdominal ultrasound will guide RF ablation of uterine
fibroids using the Halt System.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Menstrual bleeding at 12 months compared to pre-procedure (baseline)

Outcome Time Frame:

12 months from Baseline

Safety Issue:


Principal Investigator

Mary Hinckley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Reproductive Science Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

February 2014

Related Keywords:

  • Uterine Fibroids
  • Uterine Myomas
  • Uterine Fibroids
  • Myomas
  • Leiomyoma
  • Myofibroma
  • Myoma



Montefiore Medical Center Bronx, New York  10467-2490
Wayne State University Detroit, Michigan  48202
Magee-Women's Hospital Pittsburgh, Pennsylvania  15213
St. Luke's Hospital Kansas City, Missouri  64111
USC Medical Center Los Angeles, California  90033
Women's Health Research Phoenix, Arizona  85015
Pasadena Premier Women's Health Pasadena, California  91145
Reproductive Science Center San Ramon, California  94583
Athena Gynecology Medical Group Reno, Nevada  89509