A Phase 3 interventional study of ExAblate Enhanced Sonication in Uterine Leiomyoma and Uterine Fibroids, sponsored by InSightec. Completed at 5 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by InSightec · Phase 3, Interventional, and Treatment
This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.
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. InSightec has developed an Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue ablation has been added to the already FDA approved ExAblate system. The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 50 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →InSightec is the lead sponsor of 84 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention to be administered is ExAblate Enhanced Sonication. The purpose of this study is to examine the safety profile of the ExAblate Enhanced Sonication mode to insure that no new safety issues are introduced compared to the normal focused ultrasound mode.
Device: ExAblate Enhanced Sonication
Also known as: Magnetic Resonance guided Focused Ultrasound
Number of Adverse Events
The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
Time frame: Within 1 month of treatment
Mean Enhanced Sonication Normalized Thermal Dose Volume
The secondary end point of the study is to evaluate the mean normalized Enhanced Sonication thermal dose volume. Normalized dose volume is a function of the sonication dose volume divided by the energy transmitted measured from the the MR thermometry imaging.
Time frame: During treatment
Number of Participants With Adverse Events
Time frame: Within 1 month of treatment
| Milestone | Enhanced Sonication Test Arm |
|---|---|
| Started | 50 |
| Completed | 48 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Non-compliance | 1 |
The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
| Adverse Events | Enhanced Sonication Test Arm |
|---|---|
| Total Adverse Events | 77 |
| Mild/Moderate Adverse Events | 75 |
The secondary end point of the study is to evaluate the mean normalized Enhanced Sonication thermal dose volume. Normalized dose volume is a function of the sonication dose volume divided by the energy transmitted measured from the the MR thermometry imaging.
| cc/KJ/sonication | Enhanced Sonication Test Arm |
|---|---|
| Mean Enhanced Sonication Normalized Thermal Dose Volume | 0.67 ± 0.35 |
| Participants | ExAblate Enhanced Sonication Test Arm |
|---|---|
| Subjects with SAE reported | 0 |
| Subjects with no AEs reported | 13 |
| Subjects reporting AEs | 35 |
| Subject deaths | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Sonication Test Arm | 0/48 (0%) | 0/48 (0%) | 35/48 (72.9%) |
| Event | Enhanced Sonication Test Arm |
|---|---|
| Abnormal Vaginal DischargeReproductive system and breast disorders | 2/2 |
| All Pain/DiscomfortGeneral disorders | 32/48 |
| Leg pain - sonication relatedSurgical and medical procedures | 13/48 |
| Abdominal pain - sonication relatedSurgical and medical procedures | 7/48 |
| Back pain - sonication relatedSurgical and medical procedures | 7/48 |
| Skin pain - sonication relatedSurgical and medical procedures | 6/48 |
| Urinary tract infectionRenal and urinary disorders | 5/48 |
| GastrointestinalGastrointestinal disorders | 5/48 |
| Pain - sonication relatedSurgical and medical procedures | 2/48 |
| Skin burnSkin and subcutaneous tissue disorders | 1/48 |
Out of the 50 treated subjects, 48 received Enhanced Sonications (ITT) and 2 received only normal sonications.
| Age, Continuous(years) | Enhanced Sonication Test Arm |
|---|---|
| Mean | 45 ± 5.4 |
| Sex: Female, Male(Participants) | Enhanced Sonication Test Arm |
|---|---|
| Female | 48 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Enhanced Sonication Test Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 40 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Enhanced Sonication Test Arm |
|---|---|
| Canada | 11 |
| United States | 37 |
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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