Trial Outcomes & Findings for Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids (NCT NCT01946178)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).

Results posted on

2017-05-30

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	All Treated Patients All patients who underwent treatment with the device
Overall Study STARTED	73
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Treated Patients All patients who underwent treatment with the device
Overall Study Pregnancy	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Treated Patients n=73 Participants All patients who underwent treatment with the device
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	42.8 years n=93 Participants
Sex: Female, Male Female	73 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment Mexico	73 participants n=93 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	All Treated Patients n=73 Participants All patients who underwent treatment with the device	Validation Cohort With NPVs Observed The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 35 out of 36 patients (97.2%) in the Validation Cohort with NPVs observed following treatment. Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment.
Evaluation of All Adverse Events Encountered Serious Adverse Device Effects Per Patient	0 Adverse Device Effects / patient Interval 0.0 to 0.0	—
Evaluation of All Adverse Events Encountered Non-Serious Adverse Device Effects Per Patient	0.95 Adverse Device Effects / patient Interval 0.0 to 3.0	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	All Treated Patients n=33 Participants All patients who underwent treatment with the device	Validation Cohort With NPVs Observed n=35 Participants The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 35 out of 36 patients (97.2%) in the Validation Cohort with NPVs observed following treatment. Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment.
HIFU-related Non-Perfused Volume (NPV)	20.1 cubic centimeters (cc) Interval 0.6 to 123.0	46.1 cubic centimeters (cc) Interval 1.1 to 284.7

POST_HOC outcome

Timeframe: 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.

The total treatment time was measured for each patient from the beginning of HIFU energy emission until HIFU energy emission stopped.

Outcome measures

Outcome measures
Measure	All Treated Patients n=37 Participants All patients who underwent treatment with the device	Validation Cohort With NPVs Observed n=36 Participants The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 35 out of 36 patients (97.2%) in the Validation Cohort with NPVs observed following treatment. Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment.
Total Time Required to Deliver Treatment	4.9 minutes Interval 1.1 to 11.3	3.6 minutes Interval 1.5 to 9.5

Adverse Events

All Treated Patients

Serious events: 2 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Treated Patients n=73 participants at risk All patients who underwent treatment with the device
General disorders Diarrhea unrelated to treatment	1.4% 1/73 • Number of events 1 • Monitoring for Adverse Events occurred from January 8, 2011 until May 20, 2015. Adverse Events were monitored until each patient's exit from the study, which was up to 6 months following treatment. All Adverse Events are reported for all patients receiving treatment, including those events not related to treatment. Adverse Events were reported spontaneously by patients, observed by the investigator or other personnel, and/or elicited during patient queries at regular follow-up intervals. Descriptions were mapped to standardized terms.
General disorders Depressed respiration with apnea unrelated to treatment	1.4% 1/73 • Number of events 1 • Monitoring for Adverse Events occurred from January 8, 2011 until May 20, 2015. Adverse Events were monitored until each patient's exit from the study, which was up to 6 months following treatment. All Adverse Events are reported for all patients receiving treatment, including those events not related to treatment. Adverse Events were reported spontaneously by patients, observed by the investigator or other personnel, and/or elicited during patient queries at regular follow-up intervals. Descriptions were mapped to standardized terms.

Other adverse events

Other adverse events
Measure	All Treated Patients n=73 participants at risk All patients who underwent treatment with the device
General disorders Abdominal cramping pain during HIFU	57.5% 42/73 • Number of events 46 • Monitoring for Adverse Events occurred from January 8, 2011 until May 20, 2015. Adverse Events were monitored until each patient's exit from the study, which was up to 6 months following treatment. All Adverse Events are reported for all patients receiving treatment, including those events not related to treatment. Adverse Events were reported spontaneously by patients, observed by the investigator or other personnel, and/or elicited during patient queries at regular follow-up intervals. Descriptions were mapped to standardized terms.
General disorders Abdominal cramping pain post HIFU	19.2% 14/73 • Number of events 16 • Monitoring for Adverse Events occurred from January 8, 2011 until May 20, 2015. Adverse Events were monitored until each patient's exit from the study, which was up to 6 months following treatment. All Adverse Events are reported for all patients receiving treatment, including those events not related to treatment. Adverse Events were reported spontaneously by patients, observed by the investigator or other personnel, and/or elicited during patient queries at regular follow-up intervals. Descriptions were mapped to standardized terms.
General disorders Vaginal bleeding	9.6% 7/73 • Number of events 7 • Monitoring for Adverse Events occurred from January 8, 2011 until May 20, 2015. Adverse Events were monitored until each patient's exit from the study, which was up to 6 months following treatment. All Adverse Events are reported for all patients receiving treatment, including those events not related to treatment. Adverse Events were reported spontaneously by patients, observed by the investigator or other personnel, and/or elicited during patient queries at regular follow-up intervals. Descriptions were mapped to standardized terms.
General disorders Nausea with vomiting unrelated to treatment	5.5% 4/73 • Number of events 4 • Monitoring for Adverse Events occurred from January 8, 2011 until May 20, 2015. Adverse Events were monitored until each patient's exit from the study, which was up to 6 months following treatment. All Adverse Events are reported for all patients receiving treatment, including those events not related to treatment. Adverse Events were reported spontaneously by patients, observed by the investigator or other personnel, and/or elicited during patient queries at regular follow-up intervals. Descriptions were mapped to standardized terms.
General disorders Headache unrelated to treatment	5.5% 4/73 • Number of events 4 • Monitoring for Adverse Events occurred from January 8, 2011 until May 20, 2015. Adverse Events were monitored until each patient's exit from the study, which was up to 6 months following treatment. All Adverse Events are reported for all patients receiving treatment, including those events not related to treatment. Adverse Events were reported spontaneously by patients, observed by the investigator or other personnel, and/or elicited during patient queries at regular follow-up intervals. Descriptions were mapped to standardized terms.

Additional Information

Director of Clinical Affairs

Mirabilis Medica, Inc.

Phone: 425-486-8230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60