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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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17 October 2012 |
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Main ID: |
NCT01142791 |
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Date of registration:
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10/06/2010 |
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Primary sponsor: |
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Public title:
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Safety Study of ExAblate for the Treatment of Uterine Fibroids
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Scientific title:
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A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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115 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01142791 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women age 18 or older
- Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher,
based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and
Health-Related Quality of Life Questionnaire (UFS-QOL)
- Women who have given written informed consent
- Women who are able and willing to attend all study visits.
- Patient is pre or peri-menopausal (within 12 months of last menstrual period).
- Patient should be family complete.
- 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).
- Fibroids(s) clearly visible on non-contrast MRI.
- Fibroid enhances on MR contrast imaging.
Exclusion Criteria:
- Women who are pregnant, as confirmed by serum/urine test at time of screening, or
urine pregnancy test on the day of treatment.
- Patients who are breast-feeding.
- Patients with active pelvic inflammatory disease (PID).
- Patients with active local or systemic infection.
- Patients experiencing 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
- Weight greater than 250 lbs (113Kg)
- Implanted ferromagnetic materials and/or devices contraindicated for MR scan
- Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)
- Any other contraindication for MRI Scan
- Extensive abdominal scarring in the beam path (that cannot be avoided by redirection
of the beam).
- Dermoid 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.
- Pedunculated fibroids.
- Uterine size >24 weeks.
Age minimum:
18 Years
Age maximum:
N/A
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: ExAblate
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Primary Outcome(s)
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Chronic leg pain
[Time Frame: From treatment to 1-month post-treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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