Uterine Fibroids (Leiomyomas)
Conditions
Keywords
Uterine Fibroids, Leiomyomas, High-Intensity Focused Ultrasound Ablation, Ultrasonography
Brief summary
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.
Interventions
DEVICEMirabilis High-Intensity Focused Ultrasound Treatment System
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.
Sponsors
Mirabilis Medica, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Mexico
Participant flow
Recruitment details
All patients underwent transabdominal uterine fibroid treatment with the Mirabilis High-Intensity Focused Ultrasound Treatment System between January 8, 2011 and November 21, 2014 at two clinical sites in Mexico. The study was completed on May 20, 2015.
Pre-assignment details
Patients were screened prior to treatment for eligibility criteria including size, location, and tissue characteristics of their uterine fibroid(s). Those patients meeting the established eligibility criteria were then scheduled for treatment.
Participants by arm
| Arm | Count |
|---|---|
| All Treated Patients All patients who underwent treatment with the device | 73 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | All Treated Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants |
| Age, Continuous | 42.8 years |
| Region of Enrollment Mexico | 73 participants |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 73 |
| serious Total, serious adverse events | 2 / 73 |
Outcome results
Primary
Evaluation of All Adverse Events Encountered
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.
Time frame: Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).
Population: All Adverse Device Effects are reported for the entire study population (all treated patients).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Treated Patients | Evaluation of All Adverse Events Encountered | Serious Adverse Device Effects Per Patient | 0 Adverse Device Effects / patient |
| All Treated Patients | Evaluation of All Adverse Events Encountered | Non-Serious Adverse Device Effects Per Patient | 0.95 Adverse Device Effects / patient |
Secondary
HIFU-related Non-Perfused Volume (NPV)
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.
Time frame: The NPV was measured between 0 and 7 days post-treatment.
Population: HIFU-related Non-Perfused Volumes (NPVs) are reported for all treated patients in whom they were observed following treatment. NPV outcomes are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Treated Patients | HIFU-related Non-Perfused Volume (NPV) | 20.1 cubic centimeters (cc) |
| Validation Cohort With NPVs Observed | HIFU-related Non-Perfused Volume (NPV) | 46.1 cubic centimeters (cc) |
Post Hoc
Total Time Required to Deliver Treatment
The total treatment time was measured for each patient from the beginning of HIFU energy emission until HIFU energy emission stopped.
Time frame: The total treatment time was measured on the day of treatment.
Population: Total treatment times are reported for all treated patients. Total treatment times are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Treated Patients | Total Time Required to Deliver Treatment | 4.9 minutes |
| Validation Cohort With NPVs Observed | Total Time Required to Deliver Treatment | 3.6 minutes |