Uterine Fibroids (Leiomyomas) Clinical Trial
Official title:
Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia
The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.
| Status | Completed |
| Enrollment | 73 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Female - Age 18-55 years - Patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology - Patients able and willing to provide informed consent Exclusion Criteria: - Visible scar within the HIFU beam path that cannot be avoided - Known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall - Currently pregnant or desire to become pregnant in the future - Pelvic malignancy - Pelvic congenital malformation - Acute pelvic infection - Otherwise determined by a physician to be inappropriate for the study |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Hospital Torre Medica | Ciudad de Mexico | Distrito Federal |
| Mexico | Hospital Universitario, Universidad Autonoma de Nuevo Leon | Monterrey | Nuevo Leon |
| Lead Sponsor | Collaborator |
|---|---|
| Mirabilis Medica, Inc. |
Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of all adverse events encountered | Safety of the intervention will be determined by evaluating the incidence and severity of adverse events and adverse device effects. | up to 6 months | Yes |
| Secondary | Observation of tissue response via pathological assessment of fibroid specimens following hysterectomy and/or post-treatment magnetic resonance imaging (MRI) | Preliminary efficacy of the intervention will be determined by evaluating the dimensions and position of nonviable tissue observed in each fibroid specimen via pathological processing following hysterectomy and/or by assessing the non-perfused volume (NPV) observed on post-treatment contrast-enhanced MRI. | up to 6 months | No |