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MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device


Phase 3
18 Years
N/A
Not Enrolling
Female
Uterine Fibroids, Uterine Leiomyomas

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Trial Information

MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device


Inclusion Criteria:



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

2. Able and willing to give consent and able to attend all study visits.

3. Patient is pre or peri-menopausal (within 12 months of last menstrual period).

4. Able to communicate sensations during the ExAblate procedure.

5. 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).

6. Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

1. Metallic implants that are incompatible with MRI

2. Sensitive to MRI contrast agents

3. Severe claustrophobia that would prevent completion of procedure in MR unit

4. Who are pregnant or desire to become pregnant in the future. Pregnancies following
ExAblate treatment could be dangerous for both mother and fetus.

5. Pedunculated fibroids

6. Active pelvic inflammatory disease (PID)

7. Active local or systemic infection

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

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

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

11. Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g.,
due to Caesarean section or repeated abdominal surgeries)

12. Undiagnosed vaginal bleeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues.

Principal Investigator

George Holland, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lahey Clinic

Authority:

United States: Food and Drug Administration

Study ID:

UF017

NCT ID:

NCT00295217

Start Date:

February 2006

Completion Date:

October 2006

Related Keywords:

  • Uterine Fibroids
  • Uterine Leiomyomas
  • Fibroids
  • Uterine Leiomyomas
  • ExAblate
  • MrgFUS
  • Leiomyoma
  • Myofibroma

Name

Location

University of California at San DiegoLa Jolla, California  92093
Lahey ClinicBurlington, Massachusetts  01805
Cornell VascularNew York, New York  10022
KNIKalamazoo, Michigan  49048