Clinical Trials for Symptomatic Uterine Fibroids

    
    

Quick links:

Current undergoing trials:

  • The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids (NCT00995878-ClinicalTrials.gov Identifier)                                       

  • A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids  ​(NCT01285960-ClinicalTrials.gov Identifier)


The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids
(NCT00995878-ClinicalTrials.gov Identifier)  

Primary Outcome Measures:

  • Symptomatic outcomes measured by validated instruments

Secondary Outcome Measures:

  • Adverse events following treatment

  • Biologic predictors of outcome
     

Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Women able to give informed consent and willing and able to attend all study visits

  • Premenopausal women at least 25 years of age

  • No evidence of High Grade SIL by pap smears or HPV testing within institutional guidelines

Exclusion Criteria:

  • Women actively trying for pregnancy or currently pregnant

  • Uterine size > 20 weeks

  • Prior myomectomy, UAE, or MRgFUS. Previous hysteroscopic or laparoscopic myomectomy for the removal of only pedunculated leiomyomas (as described in #17, below) will be allowed and evaluated on an individual basis to determine eligibility for treatment.

  • More than 6 fibroids > than 3 centimeters in maximal diameter

  • Allergy to either gadolinium or iodinated contrast

  • Implanted metallic device prohibiting MRI

  • Severe claustrophobia

  • BMI which prohibits subject from fitting in MRI device

  • Severe abdominal scarring precluding safe MRgFUS treatment

  • Active pelvic infection

  • Intrauterine contraceptive device in place at the time of treatment

  • Current use of GnRH agonists or antagonists

  • Unstable medical conditions requiring additional monitoring during the procedure

  • Bleeding diathesis requiring medical treatment

  • Imaging suggestive of malignant disease of uterus, ovary, or cervix

  • Imaging suggestive of only adenomyosis

  • Pedunculated submucosal or subserosal myoma with a stalk less than 25% of the maximal fibroid diameter 

Contacts and Locations

USA
California
University of California 
                                                                   
San Francisco, California, 94116
Principal Investigator: Vanessa Jacoby, MD MAS        
Sub-Investigator: Maureen Kohi, MD
Contact: Stephanie Lemp   
Phone: 415-297-3114   
email: LempS@obgyn.ucsf.edu  
 
Minnesota
Mayo Clinic
                                                                                    
Rochester, Minnesota, United States, 55905
Principal Investigator: Elizabeth A. Stewart, MD
Contact: Lisa G. Peterson, RN, RN   
Phone: 507-266-4813   
Email: mayofibroids@mayo.edu  
 
North Carolina
Duke University Health System
                                                         
Durham, North Carolina, 27705
Principal Investigator: Phyllis Leppert, MD, Ph.D        
Sub-Investigator: Michael Miller, MD    
Contact: Study coordinator  
Phone: 919-668-3756 


A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids  
(NCT01285960-ClinicalTrials.gov Identifier) 

Primary Outcome Measures:

  • Leg pain or lower extremity neuropathy persisting or occuring greater than 10 days following treatment 

Eligibility

Ages Eligible for Study:   25 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


Criteria

Inclusion Criteria:

  • Patient age 18 or older

  • Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.

  • Patients who have given written informed consent

  • Patients who are able and willing to attend all study visits

  • Patients who are pre or peri-menopausal (within 12 months of last menstrual period)

  • Patients should have completed child bearing

  • Able to communicate sensations during the ExAblate procedure.

  • Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).

  • Fibroid(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

  • Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.

  • Uterine size >24 weeks.

  • Patients with pedunculated fibroids

  • Patients with active pelvic inflammatory disease (PID).

  • Patients with active local or systemic infection

  • Patients experiencing any symptoms of lower extremity neuropathy, including chronic leg or lower back pain, within the last 6 months

  • Contraindication for MRI Scan:

        - Severe claustrophobia that would prevent completion of procedure in the MR unit
        - Metallic implants that are incompatible with MRI
        - Sensitivity to MRI contrast agents
        - Any other contraindication for MRI Scan

  • Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam)

  • Demoid cyst of the ovary anywhere in the treatment path.

  • Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.

  • Intrauterine device (IUD) anywhere in the treatment path

  • Undiagnosed vaginal bleeding

 
Contacts and Locations  

USA
California
Stanford University Medical Center  
                                                
Stanford, California, 94305
Sub-Investigator: Pejman Ghanouni, MD
Contact: Fizaa Ahmed   
Phone: 650-725-6409   
email: fizaa@stanford.edu  
 
Massachusetts
Brigham and Women's Hospital     
                                                   
Boston, Massachusetts, 02115
Principal Investigator: Serene Srouji, MD
Contact: Louise Greenberg   
Phone: 617-732-5441   
email: LGREENBERG@PARTNERS.ORG  
 
Minnesota
Mayo Clinic
                                                                                    
Rochester, Minnesota, 55905
Principal Investigator: Gina Hesley, MD        
Contact: Patty Johnson, RN   
Phone: 507-538-7765   
email: FOCUSEDULTRASOUND@mayo.edu  
 
Ohio
Ohio Health Research Institute
                                                         
Columbus, Ohio, 43214
Principal Investigator: Eric Dolen, MD        
Contact: Carol Strausbaugh, RN  
Phone: 614-566-1253   
email: carol.strausbaugh@ohiohealth.com  
 
Virginia
University of Virginia Health System  
                                               
Charlottesville, Virginia, 22908
Principal Investigator: Alan Matsumoto, MD        
Contact: Brigitte Kelly   
Phone: 434-243-0315   
email: BJK3C@hscmail.mcc.virginia.edu