Trial Outcomes & Findings for Safety Study of ExAblate for the Treatment of Uterine Fibroids (NCT NCT01142791)
NCT ID: NCT01142791
Last Updated: 2019-03-19
Results Overview
The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit \> 0.90 was considered statistically successful.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
From treatment to 1-month post-treatment
Results posted on
2019-03-19
Participant Flow
The protocol defined the primary analysis to include participants receiving more than 1 sonication, i.e., 115 in this case. The safety population was defined in the protocol as participants receiving any sonications which is 121. 6 subjects receiving only 1 sonication were in the safety population but not in the baseline or primary analysis.
Participant milestones
| Measure |
ExAblate Treatment
ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation. Phase IV enhanced sonication technique.
|
Additional Safety Population Particpants
Per protocol 6 participants receiving only 1 sonication were added to the 115 ExAblate treated subjects to compose the full safety analysis population of 121. These 6 were included in adverse event reporting only, not in baseline or efficacy analyses.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
6
|
|
Overall Study
Safety
|
115
|
6
|
|
Overall Study
COMPLETED
|
108
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
ExAblate Treatment
ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation. Phase IV enhanced sonication technique.
|
Additional Safety Population Particpants
Per protocol 6 participants receiving only 1 sonication were added to the 115 ExAblate treated subjects to compose the full safety analysis population of 121. These 6 were included in adverse event reporting only, not in baseline or efficacy analyses.
|
|---|---|---|
|
Overall Study
Alternative Treatment
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Received only 1 sonication
|
0
|
6
|
Baseline Characteristics
Safety Study of ExAblate for the Treatment of Uterine Fibroids
Baseline characteristics by cohort
| Measure |
ExAblate Treatment
n=115 Participants
ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation
|
|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
European/Middle East (White)
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From treatment to 1-month post-treatmentPopulation: Per protocol the number of participants analyzed was the number of participants receiving more than one sonication. Six subjects receiving one sonication were excluded from the primary analysis but included in the safety population for a safety sample size n = 121.
The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit \> 0.90 was considered statistically successful.
Outcome measures
| Measure |
ExAblate Treatment
n=115 Participants
ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation. Phase IV enhanced sonication technique.
|
|---|---|
|
Percent Occurrence of Chronic Leg Pain
|
97 percentage of subjects without leg pain
Interval 92.0 to 99.0
|
Adverse Events
ExAblate Treatment
Serious events: 0 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ExAblate Treatment
n=121 participants at risk
ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation. Phase IV enhanced sonication technique.
|
|---|---|
|
Vascular disorders
Increased blood pressure
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Skin and subcutaneous tissue disorders
Erythema abdomen
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Skin and subcutaneous tissue disorders
Infection IV site
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Skin and subcutaneous tissue disorders
Skin burn
|
4.1%
5/121 • Number of events 5 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Surgical and medical procedures
Skin pain sonication relaed
|
44.6%
54/121 • Number of events 67 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Gastrointestinal disorders
Bloating abdomen
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Gastrointestinal disorders
Constipation
|
4.1%
5/121 • Number of events 5 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Gastrointestinal disorders
Diarrhea
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Gastrointestinal disorders
GI upset
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Gastrointestinal disorders
Heartburn
|
1.7%
2/121 • Number of events 2 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
9.1%
11/121 • Number of events 12 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Musculoskeletal and connective tissue disorders
Mass - fat necrosis
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Musculoskeletal and connective tissue disorders
Cramping position related
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Musculoskeletal and connective tissue disorders
Cramping muscle leg
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Musculoskeletal and connective tissue disorders
Pain neck/shoulder position related
|
2.5%
3/121 • Number of events 4 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Musculoskeletal and connective tissue disorders
Pubic bone soreness position related
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Musculoskeletal and connective tissue disorders
Cramping muscle inguinal
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Musculoskeletal and connective tissue disorders
Pain lower extremity position related
|
11.6%
14/121 • Number of events 15 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Musculoskeletal and connective tissue disorders
Discomfort neck/shoulder position related
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Musculoskeletal and connective tissue disorders
Tenderness abdomen position related
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Nervous system disorders
Parasthesia
|
1.7%
2/121 • Number of events 2 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Surgical and medical procedures
Cramping Sonication related
|
9.9%
12/121 • Number of events 12 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
General disorders
Cramping abdomen
|
1.7%
2/121 • Number of events 2 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
General disorders
Cramping back/buttock/leg
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Surgical and medical procedures
Pain uterine sonication related
|
1.7%
2/121 • Number of events 2 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Surgical and medical procedures
Discomfort back/buttock/leg sonication related
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Surgical and medical procedures
Pain abdomen sonication related
|
52.1%
63/121 • Number of events 78 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Surgical and medical procedures
Pain back/buttock/leg sonication related
|
57.9%
70/121 • Number of events 104 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
General disorders
Tenderness abdomen
|
2.5%
3/121 • Number of events 3 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Reproductive system and breast disorders
Edema/swelling abdome
|
2.5%
3/121 • Number of events 4 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Reproductive system and breast disorders
Amennorhia
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Reproductive system and breast disorders
Cramping menstrual
|
5.0%
6/121 • Number of events 6 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Reproductive system and breast disorders
Vaginal discharge/bleeding
|
5.8%
7/121 • Number of events 7 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
General disorders
Fatigue
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
General disorders
Fever
|
3.3%
4/121 • Number of events 4 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
General disorders
Flu
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
General disorders
Medication error
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Renal and urinary disorders
Dysuria
|
1.7%
2/121 • Number of events 2 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Renal and urinary disorders
Hematuria
|
1.7%
2/121 • Number of events 2 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Renal and urinary disorders
Infection bladder
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Renal and urinary disorders
Urinary tract infection
|
2.5%
3/121 • Number of events 3 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
Renal and urinary disorders
Cystitis
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
|
General disorders
Insomnia
|
0.83%
1/121 • Number of events 1 • 1 Month
Per protocol a predetermined sample size of 115 participants receiving more than one sonication were included in the primary analysis. An additional 6 subjects receiving a single sonication were excluded from the primary analysis but included in the adverse events analysis for a safety sample size of 121.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place