MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids

Sponsor

InSightec (Industry)

Overall Status

Completed

CT.gov ID

NCT00166270

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

11.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids	Device: ExAblate 2000	N/A

Detailed Description

After the PMA Panel, the sponsor was requested to conduct a post-approval study. The objective of this study is to gather additional data to evaluate the safety and long term effectiveness of focused ultrasound treatment, and to include a larger cohort of African-American patients. Patients will be treated following the approved commercial treatment guidelines.

Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. In general, these symptoms can be classified into two categories:

heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia.
pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis.

Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Device: ExAblate 2000

Arm

Intervention/Treatment

Experimental: 1

Device: ExAblate 2000

Outcome Measures

Primary Outcome Measures

Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement. [Within 1 month of Treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
Able and willing to give consent and able to attend all study visits.
Patient is pre or peri-menopausal (within 12 months of last menstrual period).
Able to communicate sensations during the ExAblate procedure.
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).
Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

Metallic implants that are incompatible with MRI
Sensitive to MRI contrast agents
Severe claustrophobia that would prevent completion of procedure in MR unit
Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
Pedunculated fibroids
Active pelvic inflammatory disease (PID)
Active local or systemic infection
Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
Intrauterine device (IUD) anywhere in the treatment path
Dermoid cyst of the ovary anywhere in the treatment path
Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
Undiagnosed vaginal bleeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radnet Management	Los Angeles	California	United States	90025
2	University MRI	Boca Raton	Florida	United States	33431
3	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
4	Lahey Clinic	Burlington	Massachusetts	United States	01805
5	Virtua	Voorhees	New Jersey	United States	08043
6	North Texas Uterine Fibroid Institute	Plano	Texas	United States	75093