Status:
TERMINATED
Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
Lead Sponsor:
Philips Healthcare
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatme...
Detailed Description
Uterine Fibroids are the most common benign tumors in pre- and peri-menopausal women. Fibroids occur in 20-50% of women over 30 years of age, and with increasing size can produce pain, menorrhagia, pr...
Eligibility Criteria
Inclusion
- Women, age between 18 and 50 years
- Ethnicity has a match with the intended profile for the site
- Weight \< 140kg or 310lbs
- Pre- or peri-menopausal as indicated by clinical evaluation or Follicle Stimulating Hormone (FSH) level \< 40 IU/L
- Willing and able to attend all study visits
- Willing and able to complete Menstrual Blood Loss (MBL) assessment with Alkaline Hematin (AH) method
- Willing and able to use reliable contraception methods
- Uterine size \< 24 weeks
- Cervical cell assessment by Pap smear: Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
- MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated.
- Fibroids selected for treatment meeting the following criteria (further extrapolated in the protocol):
- Total planned ablation volume of all fibroids should not exceed 250 ml and
- No more than 5 fibroids should be planned for ablation and
- Dominant fibroid (diameter) is greater than or equal to 3 cm and
- Completely non-enhancing fibroids should not be treated as the identification of treated volume becomes ambiguous
- Patient's self-assessment indicates that she has had episodes of heavy menstrual bleeding in the past 6 months.
- Menstrual Blood Loss (MBL) ≥150 ml and ≤ 500 ml
Exclusion
- Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)
- Desire for future pregnancy
- Significant systemic disease even if controlled
- Positive pregnancy test
- Hematocrit \< 25%
- Extensive scarring along anterior lower abdominal wall (\>50% of area)
- Surgical clips in the potential path of the HIFU beam
- MRI contraindicated
- MRI contrast agent contraindicated (including renal insufficiency)
- Calcifications around or throughout uterine tissues that may affect treatment
- Communication barrier
- Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU MR protocol) fibroids
- Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
- Menses lasting \> 7 days or intermenstrual bleeding (patient can be included if there is endometrial biopsy within 6 months to exclude malignancy)
- Patient is currently on hormonal medication for fibroids or has a hormonal medication history as described below:
- 1-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or
- 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or
- Depo Provera or equivalent: less than 6 months prior to MBL measurement
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01504308
Start Date
May 1 2012
End Date
March 1 2016
Last Update
April 5 2017
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Chicago
Chicago, Illinois, United States, 60637
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Montefiore Medical Center
The Bronx, New York, United States, 10467
4
Oregon Science and Health University
Portland, Oregon, United States, 97239