ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

• Sponsor: InSightec (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01285960
• Collaborator: (none)
• Enrollment: 108
• Locations: 8
• Arm: 1
• Duration (Months): 47
• Patients Per Site: 13.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.

The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate.

The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids.

The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety:

• Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid.

• Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids	Device: ExAblate Treatment UF V2	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ExAblate treatment UF V2 ExAblate MRgFUS Treatment	Device: ExAblate Treatment UF V2; Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment [From treatment to 1-month post-treatment]

   The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient age 18 or older

2. Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.

3. Patients who have given written informed consent

4. Patients who are able and willing to attend all study visits

5. Patients who are pre or peri-menopausal (within 12 months of last menstrual period)

6. Patients should have completed child bearing

7. Able to communicate sensations during the ExAblate procedure.

8. Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).

9. Fibroid(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

1. Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.

2. Uterine size >24 weeks.

3. Patients with pedunculated fibroids

4. Patients with active pelvic inflammatory disease (PID).

5. Patients with active local or systemic infection

6. Patients experiencing any symptoms of lower extremity neuropathy, including chronic leg or lower back pain, within the last 6 months

7. Contraindication for MRI Scan:

• Severe claustrophobia that would prevent completion of procedure in the MR unit

• Metallic implants that are incompatible with MRI

• Sensitivity to MRI contrast agents

• Any other contraindication for MRI Scan

1. Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam)

2. Dermoid cyst of the ovary anywhere in the treatment path.

3. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.

4. Intrauterine device (IUD) anywhere in the treatment path

5. Undiagnosed vaginal bleeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	University of California, San Francisco	San Francisco	California	United States	94107
3	Stanford University Medical Center	Stanford	California	United States	94305
4	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
5	Mayo Clinic	Rochester	Minnesota	United States	55905
6	Duke University	Durham	North Carolina	United States	27705
7	Ohio Health Research Institute	Columbus	Ohio	United States	43214
8	University of Virginia Health System	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• InSightec

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor's Web Page

Publications

None provided.

• Responsible Party: InSightec
• ClinicalTrials.gov Identifier: NCT01285960
• Other Study ID Numbers: UF031
• First Posted: Jan 28, 2011
• Last Update Posted: Mar 6, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by InSightec: Uterine fibroids; MRgFUS; ExAblate; Focused Ultrasound; Symptomatic uterine fibroids
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

Participant Flow

Arm/Group Title	ExAblate Treatment UF V2
Arm/Group Description	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.
Period Title: Overall Study
STARTED	108
COMPLETED	102
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	ExAblate Treatment UF V2
Arm/Group Description	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 Participants	108
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	46
Sex: Female, Male (Count of Participants)
Female	108 100%
Male	0 0%
Race/Ethnicity, Customized (%) [Number]
European/Middle East (White)	69
African American	14
Asian	13
Hispanic	5
Region of Enrollment (participants) [Number]
United States	108 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment
Description	The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%
Time Frame	From treatment to 1-month post-treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ExAblate Treatment UF V2
Arm/Group Description	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.
Measure Participants	106
Number (95% Confidence Interval) [Percentage of participants]	0 0%

Adverse Events

Time Frame	1 month
Adverse Event Reporting Description	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
Arm/Group Title	ExAblate Treatment UF V2
Arm/Group Description	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.
All Cause Mortality
	ExAblate Treatment UF V2
	Affected / at Risk (%)	# Events
Total	0/108 (0%)
Serious Adverse Events
	ExAblate Treatment UF V2
	Affected / at Risk (%)	# Events
Total	1/108 (0.9%)
Gastrointestinal disorders
Acute Bowel Perforation	1/108 (0.9%)	1
Other (Not Including Serious) Adverse Events
	ExAblate Treatment UF V2
	Affected / at Risk (%)	# Events
Total	102/108 (94.4%)
Blood and lymphatic system disorders
Post-embolization like symptoms	1/108 (0.9%)	1
Gastrointestinal disorders
Diarrhea	1/108 (0.9%)	1
Nausea/vomiting	2/108 (1.9%)	4
Generalized GI upset and decreased activity	1/108 (0.9%)	1
Stomach cramping	1/108 (0.9%)	1
Bloody mucus in stool	1/108 (0.9%)	1
General disorders
Left leg anterior compartment tenderness	1/108 (0.9%)	1
Decreased sensation in right foot	1/108 (0.9%)	1
IV infiltration	1/108 (0.9%)	1
Fatigue	2/108 (1.9%)	2
Nervous system disorders
Leg/calf pain	2/108 (1.9%)	2
Dizziness/vertigo	2/108 (1.9%)	2
Tingling sensation in spine	1/108 (0.9%)	1
Psychiatric disorders
Anxiety	1/108 (0.9%)	1
Renal and urinary disorders
Dysuria	4/108 (3.7%)	4
Increased urinary frequency	1/108 (0.9%)	1
Pain or burning at urinary catheter site	2/108 (1.9%)	2
Difficulty initiating urination	1/108 (0.9%)	1
Urinary incontinence	1/108 (0.9%)	1
Urinary tract infection (UTI)	5/108 (4.6%)	5
Reproductive system and breast disorders
Abdominal cramping	2/108 (1.9%)	2
Dyspareunia	1/108 (0.9%)	1
Menstrual cramping	1/108 (0.9%)	1
Back pain during period	1/108 (0.9%)	1
Vaginal discharge	1/108 (0.9%)	1
Vaginal bleeding between periods	4/108 (3.7%)	4
Skin and subcutaneous tissue disorders
Rash	3/108 (2.8%)	3
Skin burn	3/108 (2.8%)	3
Itching	1/108 (0.9%)	1
Small bruise at IV Site	1/108 (0.9%)	1
Surgical and medical procedures
Edema/Hypo-intense tissu	7/108 (6.5%)	10
Nausea/vomiting	1/108 (0.9%)	1
Position Pain	23/108 (21.3%)	23
Sonication Pain	55/108 (50.9%)	73
Sonication-related epidermal pain	49/108 (45.4%)	57
Sonication related neuromuscular pain	81/108 (75%)	121
Fever/chills	4/108 (3.7%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.