Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids

NCT00874029 | Completed Results DMC

• 1 other identifier: CP-00-0004
• Study Type: interventional
• Target: 137
• Locations: 3 countries
• Sites: 11

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.

Conditions

Uterine Fibroids; Uterine Myomas

Keywords

Uterine Fibroids; Myomas

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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)

  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.

  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)

  12 months

• Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)

  12 months

Study Arms (1)

Halt Procedure

EXPERIMENTAL

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

Interventions

Halt Procedure DEVICE

The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.

Also known as: Halt, Halt2000, The Halt System, The Halt 2000 System

Halt Procedure

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acessa Health, Inc.: lead

Study Sites (11)

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

USC Medical Center

Los Angeles, California, 90033, United States

Location

Pasadena Premier Women's Health

Pasadena, California, 91145, United States

Location

Reproductive Science Center

San Ramon, California, 94583, United States

Location

Wayne State University

Detroit, Michigan, 48034, United States

Location

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Athena Gynecology Medical Group

Reno, Nevada, 89509, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Magee-Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Hospital Universitario Esperanza

Guatemala City, Departamento de Guatemala, 01010, Guatemala

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez de la Universidad Autonoma de Nuevo Leon. Facultad de Medicina

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (6)

• 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.

  PMID: 23635746 RESULT

• 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.

  PMID: 23073229 RESULT

• 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.

  PMID: 21545960 RESULT

• 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.

  PMID: 23941588 RESULT

• 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.

  PMID: 24021910 DERIVED

• 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.

  PMID: 24018147 DERIVED

MeSH Terms

Conditions

Leiomyoma; Myoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Laura Kemp, Sr. VP Clinical Affairs
• Organization: Halt Medical, Inc

lkemp@haltmedical.com

408-375-1465

Study Officials

• 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. Jose Eleuterio Gonzalez

  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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2014
• Last Updated: July 3, 2014
• Results First Posted: July 3, 2014

Record last verified: 2014-06

Locations

US (9); GU (1); ME (1)