Trial Outcomes & Findings for Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids (NCT NCT00837161)

Last Updated: 2012-12-04

Results Overview

The number of treatment-related Adverse Events (AE) reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of treatment-related Adverse Events per subject. Relatedness of an AE to the treatment was judged case-by-case by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

end of follow-up (date of hysterectomy, at latest day 30 after treatment)

Results posted on

2012-12-04

Participant Flow

The first High Intensity Focused Ultrasound (HIFU) treatment was on February 8, 2009 and the last patient was treated on March 5, 2010. 2 study sites enrolled patients, 2 from St. Lukes in Houston, TX and 9 from National Institutes of Health in Bethesda, MD.

Patients were screened prior to treatment and the primary exclusion criteria was either uterine size per gestational age or fibroid size.

Participant milestones

Participant milestones
Measure	HIFU Treated Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	HIFU Treated Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
Overall Study refused hysterectomy	2

Baseline Characteristics

Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIFU Treated n=11 Participants Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	46.7 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: end of follow-up (date of hysterectomy, at latest day 30 after treatment)

Population: Safety was assessed per protocol; all 11 participants were evaluated for adverse events after HIFU treatment.

Outcome measures

Outcome measures
Measure	HIFU Treated n=11 Participants Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids	1.3 treatment-related AE/patient Full Range 1.3 • Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Day 0, Hysterectomy

Population: All participants who underwent hysterectomy following MR-HIFU treatment were included in this endpoint measure. Patients who refused hysterectomy were not included.

Count the number of participants in which both of the following conditions are satisfied: the fibroid treated area as shown on MRI images during treatment is the same as displayed on fibroids from histology slices after hysterectomy, and no unintended lesions are visible in the uterus.

Outcome measures

Outcome measures
Measure	HIFU Treated n=9 Participants Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
HIFU Treatment Equals Location Per Hysterectomy	9 participants

SECONDARY outcome

Timeframe: end of follow-up (date of hysterectomy, at latest day 30 after treatment)]

Population: per protocol

Length of time to return to normal activity measured in number of days from HIFU treatment. Assessed by patient interviews during follow-up.

Outcome measures

Outcome measures
Measure	HIFU Treated n=11 Participants Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
Length of Time to Return to Normal Activities	1.4 days Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks

Population: Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point. Analysed subject numbers were: from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;

Pain Scores obtained by patient self-assessment on a 0-10 scale, with 0 corresponding to no pain and 10 corresponding to maximum pain.

Outcome measures

Outcome measures
Measure	HIFU Treated n=11 Participants Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
Numerical Range Scale (NRS) of Pain Level Treatment Day: Baseline	1.3 units on a scale Full Range 1.7 • Interval 0.0 to 5.0
Numerical Range Scale (NRS) of Pain Level Treatment Day: Recovery	2.6 units on a scale Interval 0.0 to 6.0
Numerical Range Scale (NRS) of Pain Level Treatment Day: Discharge	1.4 units on a scale Interval 0.0 to 6.0
Numerical Range Scale (NRS) of Pain Level 24 hours after treatment	2.4 units on a scale Interval 0.0 to 6.0
Numerical Range Scale (NRS) of Pain Level 48 hours after treatment	1.5 units on a scale Interval 0.0 to 5.0
Numerical Range Scale (NRS) of Pain Level 72 hours after treatment	1.3 units on a scale Interval 0.0 to 4.0
Numerical Range Scale (NRS) of Pain Level 1 week after treatment	1.2 units on a scale Interval 0.0 to 3.0
Numerical Range Scale (NRS) of Pain Level 2 weeks after treatment	1.5 units on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks

Patient's self-assessed discomfort level on a 4-point scale, with: 0 = no pain; 1 = mild; 2 = moderate; 3 = severe.

Outcome measures

Outcome measures
Measure	HIFU Treated n=11 Participants Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
Discomfort Level Treatment Day: Baseline	0.7 units on a scale Interval 0.0 to 2.0
Discomfort Level Treatment Day: Recovery	0.8 units on a scale Interval 0.0 to 2.0
Discomfort Level Treatment Day: Discharge	0.5 units on a scale Interval 0.0 to 2.0
Discomfort Level 24 hours after treatment	0.8 units on a scale Interval 0.0 to 2.0
Discomfort Level 48 hours after treatment	0.6 units on a scale Interval 0.0 to 2.0
Discomfort Level 72 hours after treatment	0.7 units on a scale Interval 0.0 to 2.0
Discomfort Level 1 week after treatment	0.3 units on a scale Interval 0.0 to 1.0
Discomfort Level 2 weeks after treatment	1.3 units on a scale Interval 0.0 to 3.0

Adverse Events

HIFU Treatment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HIFU Treatment n=11 participants at risk
Musculoskeletal and connective tissue disorders Neck Pain	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Musculoskeletal and connective tissue disorders Pain at Rib Cage or Chest Level	18.2% 2/11 • Number of events 4 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Musculoskeletal and connective tissue disorders Right leg pain	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Musculoskeletal and connective tissue disorders Lower back pain	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Gastrointestinal disorders Rectal Bleeding	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Reproductive system and breast disorders Fatigue	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Gastrointestinal disorders Diarrhea	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Musculoskeletal and connective tissue disorders Shin discomfort	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Musculoskeletal and connective tissue disorders pain right buttock	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
General disorders Pruritis	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Musculoskeletal and connective tissue disorders Shoulder pain	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Musculoskeletal and connective tissue disorders Right foot swelling	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
General disorders Fever	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
General disorders Cold	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Gastrointestinal disorders Constipation	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Injury, poisoning and procedural complications Sharp burning pain at abdomen	9.1% 1/11 • Number of events 1 • Feb 9, 2009 through March 9, 2010 Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.

Additional Information

Sarah Baxter

Philips Healthcare

Phone: 425-487-7665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60