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| ID | Type | Description | Link |
|---|---|---|---|
| Continued Access |
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The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExAblate 2000 | Device |
| Measure | Description | Time Frame |
|---|---|---|
| In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Holland, M.D. | Lahey Clinic | Principal Investigator |
| Mark Shaman, M.D. | KNI | Principal Investigator |
| Robert Min, M.D. | Cornell | Principal Investigator |
| Anne Roberts, M.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Diego | La Jolla | California | 92037 | United States | ||
| Lahey Clinic |
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| Label | URL |
|---|---|
| Sponsor web page | View source |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Burlington |
| Massachusetts |
| 01805 |
| United States |
| KNI | Kalamazoo | Michigan | 49048 | United States |
| Cornell Vascular | New York | New York | 10022 | United States |
| D009372 | Neoplasms, Connective Tissue |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |