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


Phase 4
18 Years
N/A
Not Enrolling
Female
Uterine Fibroids

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

Within 1 month of Treatment

Safety Issue:

No

Principal Investigator

Phyllis Gee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Texas UFI

Authority:

United States: Food and Drug Administration

Study ID:

UF014

NCT ID:

NCT00166270

Start Date:

January 2005

Completion Date:

January 2009

Related Keywords:

  • Uterine Fibroids
  • Fibroids
  • ExAblate
  • MrgFus
  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

Lahey ClinicBurlington, Massachusetts  01805
Brigham & Women's HospitalBoston, Massachusetts  02115
University MRIBoca Raton, Florida  33431
VirtuaVoorhees, New Jersey  08043
Radnet ManagementLos Angeles, California  90025
North Texas Uterine Fibroid InstitutePlano, Texas  75093