N/A
N=9
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
Leiomyoma
Bottom Line
View on ClinicalTrials.gov: NCT00131365 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Number and Type of Adverse Events — 15 Adverse Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ExAblate 2000 (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- InSightec
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Type of Adverse Events |
15 | — |
Summary
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment.
Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.'
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 magnetic resonance imaging (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
- Women 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
Data sourced from ClinicalTrials.gov (NCT00131365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.