Status:
COMPLETED
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
Lead Sponsor:
InSightec
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18+ years
Phase:
NA
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 3...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00166270
Start Date
January 1 2005
End Date
January 1 2009
Last Update
July 9 2018
Active Locations (6)
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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