MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation
NCT ID: NCT00295217
Last Updated: 2018-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
15 participants
INTERVENTIONAL
2006-02-28
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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ExAblate 2000
Eligibility Criteria
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Inclusion Criteria
2. Able and willing to give consent and able to attend all study visits.
3. Patient is pre or peri-menopausal (within 12 months of last menstrual period).
4. Able to communicate sensations during the ExAblate procedure.
5. 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).
6. Fibroids(s) clearly visible on non-contrast MRI.
Exclusion Criteria
2. Sensitive to MRI contrast agents
3. Severe claustrophobia that would prevent completion of procedure in MR unit
4. Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
5. Pedunculated fibroids
6. Active pelvic inflammatory disease (PID)
7. Active local or systemic infection
8. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
9. Intrauterine device (IUD) anywhere in the treatment path
10. Dermoid cyst of the ovary anywhere in the treatment path
11. Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
12. Undiagnosed vaginal bleeding
18 Years
FEMALE
Yes
Sponsors
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InSightec
INDUSTRY
Principal Investigators
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George Holland, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lahey Clinic
Mark Shaman, M.D.
Role: PRINCIPAL_INVESTIGATOR
KNI
Robert Min, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cornell
Anne Roberts, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California at San Diego
La Jolla, California, United States
Lahey Clinic
Burlington, Massachusetts, United States
KNI
Kalamazoo, Michigan, United States
Cornell Vascular
New York, New York, United States
Countries
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Related Links
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Sponsor web page
Other Identifiers
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Continued Access
Identifier Type: -
Identifier Source: secondary_id
UF017
Identifier Type: -
Identifier Source: org_study_id