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

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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Fibroids; Uterine Myomas
• Intervention / Treatment: Device: Halt Procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guatemala
  • Guatemala City, Guatemala, 01010
    • Hospital Universitario Esperanza
• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez de la Universidad Autonoma de Nuevo Leon. Facultad de Medicina
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Women's Health Research
  • California
    • Los Angeles, California, United States, 90033
      • USC Medical Center
    • Pasadena, California, United States, 91145
      • Pasadena Premier Women's Health
    • San Ramon, California, United States, 94583
      • Reproductive Science Center
  • Michigan
    • Detroit, Michigan, United States, 48034
      • Wayne State University
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Hospital
  • Nevada
    • Reno, Nevada, United States, 89509
      • Athena Gynecology Medical Group
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Halt Procedure; In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.	Device: Halt Procedure; The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.; Other Names: Halt; Halt2000; The Halt System; The Halt 2000 System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure	Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.	12 months from Baseline
Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure	An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).	12 months
Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment	Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.	12 months from Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.	12 month from Baseline
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.	The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life. Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates "change" in symptoms, a negative number indicates a reduction in symptoms and therefore improvement. Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates "change" in health and quality of life, a positive number indicates and improvement.	12 months from Baseline
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)	The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.	12 months
Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)	The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.	12 months

Collaborators and Investigators

• Sponsor: Acessa Health, Inc.
• Investigators: Principal Investigator: Mary Hinckley, MD, Reproductive Science Center; Principal Investigator: Micah Harris, MD, Women's Health Research; Principal Investigator: Erika Banks, MD, Montefiore Medical Center; Principal Investigator: Karen R Abbott, MD, Athena Gynecology Medical Group; Principal Investigator: Jay Berman, MD, Wayne State University; Principal Investigator: Jose G Garza Leal, MD, Hospital Universitario Dr. José Eleuterio González; Principal Investigator: David Levine, MD, St. Johns' Mercy Medical Center; Principal Investigator: Rodolfo Robles Pemueller, MD, Universidad Francisco Marroquín; Principal Investigator: Jennifer Israel, MD, University of Southern California; Principal Investigator: Richard S Guido, MD, Magee-Women's Hospital; Principal Investigator: James Macer, MD, Pasadena Premier Women's Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 1, 2009
• First Submitted That Met QC Criteria: April 1, 2009
• First Posted (Estimate): April 2, 2009

Study Record Updates

• Last Update Posted (Estimate): July 3, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Uterine Fibroids; Myomas
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: CP-00-0004