Clinical trial NCT00874029: Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
Official title: Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Uterine Myomas
Keywords: Uterine Fibroids
Myomas
Lead sponsor: Acessa Health, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 137
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.

Detailed description: 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.

Eligibility criteria: 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 international normalized ratio (INR), Platelets, Prothrombin Time, and Partial Thromboplastin Time (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 Gonadotropin-releasing hormone (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 Follicular Stimulating Hormone level of ≥ 25 International Units (IU) or menopausal
* Are unable to give informed consent
* In the medical judgment of the investigator should not participate in the study

Primary outcomes:
measure: Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure
timeFrame: 12 months from Baseline
measure: Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure
timeFrame: 12 months
measure: Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment
timeFrame: 12 months from Baseline
Secondary outcomes:
measure: Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging)
timeFrame: 12 month from Baseline
measure: Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool.
timeFrame: 12 months from Baseline
measure: Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome)
timeFrame: 12 months
measure: Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Los Angeles
country: United States
facility: USC Medical Center
state: California
city: Pasadena
country: United States
facility: Pasadena Premier Women's Health
state: California
city: San Ramon
country: United States
facility: Reproductive Science Center
state: California
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Reno
country: United States
facility: Athena Gynecology Medical Group
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital
state: Pennsylvania
city: Guatemala City
country: Guatemala
facility: Hospital Universitario Esperanza
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez de la Universidad Autonoma de Nuevo Leon. Facultad de Medicina
state: Nuevo Leon
Study officials:
affiliation: Reproductive Science Center
name: Mary Hinckley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's Health Research
name: Micah Harris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: Erika Banks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Athena Gynecology Medical Group
name: Karen R Abbott, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Jay Berman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Dr. Jose Eleuterio Gonzalez
name: Jose G Garza Leal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Johns' Mercy Medical Center
name: David Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Francisco Marroquín
name: Rodolfo Robles Pemueller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Jennifer Israel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Magee-Women's Hospital
name: Richard S Guido, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pasadena Premier Women's Health
name: James Macer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chudnoff SG, Berman JM, Levine DJ, Harris M, Guido RS, Banks E. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol. 2013 May;121(5):1075-1082. doi: 10.1097/AOG.0b013e31828b7962.
citation: Robles R, Aguirre VA, Argueta AI, Guerrero MR. Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up. Int J Gynaecol Obstet. 2013 Jan;120(1):65-9. doi: 10.1016/j.ijgo.2012.07.023. Epub 2012 Oct 14.
citation: Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Lee BB. Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System. J Minim Invasive Gynecol. 2011 May-Jun;18(3):364-71. doi: 10.1016/j.jmig.2011.02.006.
citation: Guido RS, Macer JA, Abbott K, Falls JL, Tilley IB, Chudnoff SG. Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years' outcome from the Halt trial. Health Qual Life Outcomes. 2013 Aug 13;11:139. doi: 10.1186/1477-7525-11-139.
citation: Levine DJ, Berman JM, Harris M, Chudnoff SG, Whaley FS, Palmer SL. Sensitivity of myoma imaging using laparoscopic ultrasound compared with magnetic resonance imaging and transvaginal ultrasound. J Minim Invasive Gynecol. 2013 Nov-Dec;20(6):770-4. doi: 10.1016/j.jmig.2013.04.015. Epub 2013 Sep 8.
citation: Galen DI, Isaacson KB, Lee BB. Does menstrual bleeding decrease after ablation of intramural myomas? A retrospective study. J Minim Invasive Gynecol. 2013 Nov-Dec;20(6):830-5. doi: 10.1016/j.jmig.2013.05.007. Epub 2013 Sep 7.