Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids

Uterine Fibroids Clinical Trial

— Halt  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874029
• Other study ID #: CP-00-0004
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: June 3, 2014
• Start date: March 2009
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: Halt Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: March 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids
• Uterine Myomas

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Halt Medical, Inc

Countries where clinical trial is conducted

United States,  Guatemala,  Mexico, 

References & Publications (4)

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):1075-82. doi: 10.1097/AOG.0b013e31828b7962. — View 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 M — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No