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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
NCT01504308 |
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Date of registration:
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03/01/2012 |
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Primary sponsor: |
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Public title:
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Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
SOFIA |
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Scientific title:
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Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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224 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01504308 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Korea, Republic of
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United States
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Contacts
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Name:
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Sarah Baxter |
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Address:
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Telephone:
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Email:
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sarah.baxter@philips.com |
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Affiliation:
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Name:
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Kelvin Hong, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins Hospital, Baltimore, Maryland, United States |
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Name:
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Hyo Keun Lim, MD |
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Address:
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Email:
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Affiliation:
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Samsung Medical Center, Seoul, Republic of Korea |
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Name:
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John H Fischer II, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Luke's Episcopal Hospital, Houston, Texas, United States |
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Name:
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Robert K Zurawin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Luke's Episcopal Hospital, Houston, Texas, United States |
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Name:
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Elizabeth David, MD |
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Address:
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Email:
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Affiliation:
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Sunnybrook Health Sciences Center, Toronto, Ontario, Canada |
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Name:
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Aytekin Oto, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Chicago, Chicago, Illinois, United States |
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Name:
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Peter Liu, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Name:
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Amanda Yunker, D.O. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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):
1. Total planned ablation volume of all fibroids should not exceed 250 ml and
2. No more than 5 fibroids should be planned for ablation and
3. Dominant fibroid (diameter) is greater than or equal to 3 cm and
4. 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 Criteria:
- 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. 1-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or
2. 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement
or
3. Depo Provera or equivalent: less than 6 months prior to MBL measurement
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Uterine Fibroids
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Intervention(s)
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Device: MR-HIFU treatment
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Device: Sham treatment
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Primary Outcome(s)
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Alternative Interventional Treatment (AIT)
[Time Frame: 12 months after HIFU treatment]
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Menstrual Blood Loss (MBL)
[Time Frame: at baseline and at 12 months following treatment]
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Secondary Outcome(s)
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Return to Activity
[Time Frame: 72 hours]
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Symptom Severity Score (SSS)
[Time Frame: at baseline and at 12 months following treatment]
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Secondary ID(s)
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994045
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G110008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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