Clinical trial NCT00166270: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
Official title: Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Keywords: Fibroids
ExAblate
MrgFus
Uterine Fibroids
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement.
timeFrame: Within 1 month of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Radnet Management
state: California
city: Boca Raton
country: United States
facility: University MRI
state: Florida
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Voorhees
country: United States
facility: Virtua
state: New Jersey
city: Plano
country: United States
facility: North Texas Uterine Fibroid Institute
state: Texas
Study officials:
affiliation: North Texas UFI
name: Phyllis Gee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Virtua
name: Paul Curtis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahey Clinic
name: George Holland, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radnet Management
name: Dennis Sarti, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy MRI
name: Fred Steinberg, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Elizabeth Stewart, M.D.
role: PRINCIPAL_INVESTIGATOR
References: