MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
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ClinicalTrials.gov Identifier: NCT00365989 |
Recruitment Status
:
Completed
First Posted
: August 18, 2006
Last Update Posted
: March 29, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uterine Leiomyoma Uterine Fibroids | Device: ExAblate 2000 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 | Device: ExAblate 2000 |
- The primary end point is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced. [ Time Frame: Within 1 month of treatment ]
- The secondary end point of the study is to evaluate the ratio of normalized Enhanced Sonication thermal dose volume Vs. that of 'nominal' sonication. [ Time Frame: Within 1 month of treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women age 18 or older, who present with symptomatic fibroids
- 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).
- 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.
Exclusion Criteria:
- Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
- Patient who desire to become pregnant in the future.
- Patients who are breast-feeding.
- Patients with an active pelvic inflammatory disease (PID)
- Active local or systemic infection
- Metallic implants that are incompatible with MRI
- Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
- Severe claustrophobia that would prevent completion of procedure in the MR unit.
- Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path.
- Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
- Pedunculated fibroids.
- Intrauterine device (IUD) anywhere in the treatment path
- Undiagnosed vaginal bleeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365989
United States, California | |
University of California at San Diego | |
La Jolla, California, United States, 92037 | |
United States, Massachusetts | |
Lahey Clinic | |
Burlington, Massachusetts, United States, 01805 | |
United States, Michigan | |
KNI | |
Kalamazoo, Michigan, United States, 49048 | |
United States, New York | |
Cornell Vascular | |
New York, New York, United States, 10022 | |
Canada, Ontario | |
Toronto General Hospital | |
Toronto, Ontario, Canada, MG5 2C4 |
Principal Investigator: | Anne Roberts, M.D. | University of California, San Diego | |
Principal Investigator: | Mark Shaman, M.D. | KNI | |
Principal Investigator: | Robert Min, M.D. | Cornell | |
Principal Investigator: | David Gianfelice, M.D. | Toronto General Hospital | |
Principal Investigator: | George Holland, M.D. | Lahey Clinic |
Additional Information:
Responsible Party: | InSightec |
ClinicalTrials.gov Identifier: | NCT00365989 History of Changes |
Other Study ID Numbers: |
UF018 |
First Posted: | August 18, 2006 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | March 2018 |
Keywords provided by InSightec:
Fibroids leiomyoma neoplasm benign tumors |
Additional relevant MeSH terms:
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |