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

Primary Purpose

Uterine Fibroids, Uterine Myomas

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Halt Procedure
Sponsored by
Acessa Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine Fibroids, Myomas

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Women's Health Research
  • USC Medical Center
  • Pasadena Premier Women's Health
  • Reproductive Science Center
  • Wayne State University
  • St. Luke's Hospital
  • Athena Gynecology Medical Group
  • Montefiore Medical Center
  • Magee-Women's Hospital
  • Hospital Universitario Esperanza
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez de la Universidad Autonoma de Nuevo Leon. Facultad de Medicina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Halt Procedure

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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).
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 1, 2009
Last Updated
June 3, 2014
Sponsor
Acessa Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00874029
Brief Title
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
Acronym
Halt
Official Title
Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acessa Health, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Uterine Myomas
Keywords
Uterine Fibroids, Myomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Halt Procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Halt Procedure
Other Intervention Name(s)
Halt, Halt2000, The Halt System, The Halt 2000 System
Intervention Description
The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.
Primary Outcome Measure Information:
Title
Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure
Description
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.
Time Frame
12 months from Baseline
Title
Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure
Description
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).
Time Frame
12 months
Title
Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment
Description
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.
Time Frame
12 months from Baseline
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
12 month from Baseline
Title
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.
Description
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.
Time Frame
12 months from Baseline
Title
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)
Description
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.
Time Frame
12 months
Title
Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)
Description
The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Hinckley, MD
Organizational Affiliation
Reproductive Science Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Micah Harris, MD
Organizational Affiliation
Women's Health Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erika Banks, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen R Abbott, MD
Organizational Affiliation
Athena Gynecology Medical Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jay Berman, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose G Garza Leal, MD
Organizational Affiliation
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Levine, MD
Organizational Affiliation
St. Johns' Mercy Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodolfo Robles Pemueller, MD
Organizational Affiliation
Universidad Francisco Marroquín
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Israel, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard S Guido, MD
Organizational Affiliation
Magee-Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Macer, MD
Organizational Affiliation
Pasadena Premier Women's Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Health Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pasadena Premier Women's Health
City
Pasadena
State/Province
California
ZIP/Postal Code
91145
Country
United States
Facility Name
Reproductive Science Center
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Athena Gynecology Medical Group
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Magee-Women's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hospital Universitario Esperanza
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez de la Universidad Autonoma de Nuevo Leon. Facultad de Medicina
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
23635746
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.
Results Reference
result
PubMed Identifier
23073229
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.
Results Reference
result
PubMed Identifier
21545960
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.
Results Reference
result
PubMed Identifier
23941588
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.
Results Reference
result
PubMed Identifier
24021910
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.
Results Reference
derived
PubMed Identifier
24018147
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.
Results Reference
derived

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Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids

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