Trial Outcomes & Findings for ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids (NCT NCT01285960)
NCT ID: NCT01285960
Last Updated: 2019-03-06
Results Overview
The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
From treatment to 1-month post-treatment
Results posted on
2019-03-06
Participant Flow
Participant milestones
| Measure |
ExAblate Treatment UF V2
ExAblate MRgFUS Treatment
ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
ExAblate Treatment UF V2
ExAblate MRgFUS Treatment
ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
2 subjects received less 10 sonications
|
2
|
Baseline Characteristics
ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
Baseline characteristics by cohort
| Measure |
ExAblate Treatment UF V2
n=108 Participants
ExAblate MRgFUS Treatment
ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
|
|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
European/Middle East (White)
|
69 %
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
14 %
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 %
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 %
n=5 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From treatment to 1-month post-treatmentPopulation: Per protocol 2 subjects receiving \< 10 sonications were excluded from the safety sample size of 108 for an primary safety analysis sample size of 106.
The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%
Outcome measures
| Measure |
ExAblate Treatment UF V2
n=106 Participants
ExAblate MRgFUS Treatment
ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
|
|---|---|
|
Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment
|
0 Percentage of participants
Interval 0.0 to 5.6
|
Adverse Events
ExAblate Treatment UF V2
Serious events: 1 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ExAblate Treatment UF V2
n=108 participants at risk
ExAblate MRgFUS Treatment
ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
|
|---|---|
|
Gastrointestinal disorders
Acute Bowel Perforation
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
Other adverse events
| Measure |
ExAblate Treatment UF V2
n=108 participants at risk
ExAblate MRgFUS Treatment
ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
3/108 • Number of events 3 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Skin and subcutaneous tissue disorders
Skin burn
|
2.8%
3/108 • Number of events 3 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Skin and subcutaneous tissue disorders
Small bruise at IV Site
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Surgical and medical procedures
Edema/Hypo-intense tissu
|
6.5%
7/108 • Number of events 10 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Surgical and medical procedures
Nausea/vomiting
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Gastrointestinal disorders
Diarrhea
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Gastrointestinal disorders
Nausea/vomiting
|
1.9%
2/108 • Number of events 4 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Gastrointestinal disorders
Generalized GI upset and decreased activity
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Gastrointestinal disorders
Stomach cramping
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Gastrointestinal disorders
Bloody mucus in stool
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Reproductive system and breast disorders
Abdominal cramping
|
1.9%
2/108 • Number of events 2 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Reproductive system and breast disorders
Menstrual cramping
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Reproductive system and breast disorders
Back pain during period
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Reproductive system and breast disorders
Vaginal bleeding between periods
|
3.7%
4/108 • Number of events 4 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Psychiatric disorders
Anxiety
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Nervous system disorders
Leg/calf pain
|
1.9%
2/108 • Number of events 2 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Nervous system disorders
Dizziness/vertigo
|
1.9%
2/108 • Number of events 2 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Nervous system disorders
Tingling sensation in spine
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
General disorders
Left leg anterior compartment tenderness
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
General disorders
Decreased sensation in right foot
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
General disorders
IV infiltration
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Surgical and medical procedures
Position Pain
|
21.3%
23/108 • Number of events 23 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Surgical and medical procedures
Sonication Pain
|
50.9%
55/108 • Number of events 73 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Surgical and medical procedures
Sonication-related epidermal pain
|
45.4%
49/108 • Number of events 57 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Surgical and medical procedures
Sonication related neuromuscular pain
|
75.0%
81/108 • Number of events 121 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
General disorders
Fatigue
|
1.9%
2/108 • Number of events 2 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Surgical and medical procedures
Fever/chills
|
3.7%
4/108 • Number of events 5 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Blood and lymphatic system disorders
Post-embolization like symptoms
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Renal and urinary disorders
Dysuria
|
3.7%
4/108 • Number of events 4 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Renal and urinary disorders
Increased urinary frequency
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Renal and urinary disorders
Pain or burning at urinary catheter site
|
1.9%
2/108 • Number of events 2 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Renal and urinary disorders
Difficulty initiating urination
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Renal and urinary disorders
Urinary incontinence
|
0.93%
1/108 • Number of events 1 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
|
Renal and urinary disorders
Urinary tract infection (UTI)
|
4.6%
5/108 • Number of events 5 • 1 month
2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place