Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids

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Спонзори

Mirabilis Medica, Inc.

КЛИНИЧКО ИСПИТУВАЊЕ: NCT01946178

BioSeek: nct01946178

Клучни зборови

Апстракт

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.

Датуми

Последен пат проверено:	03/31/2017
Прво доставено:	09/15/2013
Поднесено е проценето запишување:	09/15/2013
Прво објавено:	09/18/2013
Последното ажурирање е доставено:	04/27/2017
Последно ажурирање објавено:	05/29/2017
Датум на први доставени резултати:	02/23/2016
Датум на први доставени резултати за КК:	02/23/2016
Датум на објавување на првите резултати:	03/24/2016
Крај на датумот на започнување на студијата:	12/31/2010
Проценет датум на примарно завршување:	04/30/2015
Проценет датум на завршување на студијата:	04/30/2015

Состојба или болест

Uterine Fibroids (Leiomyomas)

Интервенција / третман

Device: Focused ultrasound treatment

Фаза

Групи за раце

Рака	Интервенција / третман
Experimental: Focused ultrasound treatment Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System.	Device: Focused ultrasound treatment The intervention consists of a treatment session with the device, during which focused ultrasound energy is applied across the intact abdominal wall to ablate appropriately selected uterine fibroids under ultrasound imaging guidance.

Критериуми за подобност

Возраст подобни за студии	18 Years До 18 Years
Полови квалификувани за студии	Female
Прифаќа здрави волонтери	Да
Критериуми	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

Исход

Мерки на примарниот исход

1. Evaluation of All Adverse Events Encountered [Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).]

Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.

Секундарни мерки на исходот

1. HIFU-related Non-Perfused Volume (NPV) [The NPV was measured between 0 and 7 days post-treatment.]

Efficacy of the treatment was quantified by measuring the HIFU-related Non-Perfused Volume (NPV) of tissue in each patient using either post-treatment contrast-enhanced magnetic resonance imaging (MRI) or pathology assessment following hysterectomy. The NPV is used to measure the amount of tissue that was treated during the procedure.

Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids

Клучни зборови

fibroma

leiomyoma corporis uteri

mirabilis

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