Trial Outcomes & Findings for Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids (NCT NCT00897897)

NCT ID: NCT00897897

Last Updated: 2012-12-04

Results Overview

The number of Adverse Events reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of Adverse Events per subject.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: 30 days after treatment
• Results posted on: 2012-12-04

Participant Flow

Enrollment was initiated on March 19, 2009 and completed on April 24, 2010.

Participant milestones

Measure	Treated Leiomyomas Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study. Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment.
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids

Baseline characteristics by cohort

Measure	Treated Leiomyomas n=33 Participants Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study. Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	44.8 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment France	16 participants n=5 Participants
Region of Enrollment Germany	4 participants n=5 Participants
Region of Enrollment Netherlands	3 participants n=5 Participants
Region of Enrollment Korea, Republic of	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after treatment

The number of Adverse Events reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of Adverse Events per subject.

Outcome measures

Measure

Treated Leiomyomas n=33 Participants Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study. Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment.

Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids

2.6 Adverse Event/subject Standard Deviation 2.6

SECONDARY outcome

Timeframe: At baseline and at 30 days following treatment

Mean absolute change in the Symptom Severity Score (SSS) of the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) questionnaire after fibroid treatment with HIFU.

The SSS is a scale from 0-100, where 0 corresponds to no symptoms and 100 corresponds to the most severe symptoms.

Outcome measures

Measure

Treated Leiomyomas n=33 Participants Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study. Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment.

Fibroid Symptom Severity Score (SSS) From the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) Questionnaire.

-13.6 scores on a scale Standard Deviation 17.7

Adverse Events

Treated Leiomyomas

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treated Leiomyomas n=33 participants at risk Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study. Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment.
General disorders Abdominal Pain	30.3% 10/33 • Number of events 10 • Adverse Event information was collected from baseline to 30 days after treatment, i.e. 30 days
General disorders Back Pain	12.1% 4/33 • Number of events 4 • Adverse Event information was collected from baseline to 30 days after treatment, i.e. 30 days
General disorders Bloating	12.1% 4/33 • Number of events 4 • Adverse Event information was collected from baseline to 30 days after treatment, i.e. 30 days
General disorders Fatigue and Tiredness	18.2% 6/33 • Number of events 6 • Adverse Event information was collected from baseline to 30 days after treatment, i.e. 30 days
General disorders Headache	9.1% 3/33 • Number of events 3 • Adverse Event information was collected from baseline to 30 days after treatment, i.e. 30 days
General disorders Nausea	6.1% 2/33 • Number of events 2 • Adverse Event information was collected from baseline to 30 days after treatment, i.e. 30 days
General disorders Vaginal Bleeding	6.1% 2/33 • Number of events 2 • Adverse Event information was collected from baseline to 30 days after treatment, i.e. 30 days
General disorders Urinary Burning	9.1% 3/33 • Number of events 3 • Adverse Event information was collected from baseline to 30 days after treatment, i.e. 30 days

Additional Information

Director, Clinical and Regulatory Affairs

Philips Healthcare

Phone: 425-487-7665

Email: sarah.baxter@philips.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60