Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

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.

ExAblate Enhanced Sonication

Anne Roberts, M.D.

Mark Shaman, M.D.

Robert Min, M.D.

David Gianfelice, M.D.

George Holland, M.D.

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.

MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

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.

The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.

InSightec

ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.

Enhanced Sonication Test Arm

Age, Continuous

Only women with uterine fibroids qualified for this study.

Sex: Female, Male

Race (NIH/OMB)

Canada

United States

Region of Enrollment

Out of the 50 treated subjects, 48 received Enhanced Sonications (ITT) and 2 received only normal sonications.

Nadir Alikacem

Total Adverse Events

Mild/Moderate Adverse Events

Number of Adverse Events

Of the 50 subjects treated, 39 were included in the thermal analysis per the protocol. Of the 11 subjects not eligible, 8 were not treated with at least 30% enhanced sonications. Three subjects received enhanced sonications at tissue depths greater that 70 mm from the skin line.

Mean Enhanced Sonication Normalized Thermal Dose Volume

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.

ExAblate Enhanced Sonication

ExAblate Enhanced Sonication Test Arm

Number of Participants With Adverse Events

Overall Study

Diseases and Abnormalities at or Before Birth

Heart and Blood Diseases

Congenital Abnormalities

Vascular Malformations

Cardiovascular Abnormalities

Subjects randomized to control will receive additional dural sutures as deemed necessary by the surgeon. CSF leakage will be re-evaluated with the Valsalva maneuver to 10-20 cm H2O for 5 to 10 seconds. Closure of the remaining layers of the surgical site will be performed according to the surgeon's standard of practice.

Subjects randomized to receive Bioseal, a thin layer will be applied to the entire length of the suture line and the adjacent area to approximately 5mm away, including all suture holes. Up to two layers of Bioseal may be used for each application. While Bioseal achieves complete coagulation, CSF leakage will be re-evaluated with the Valsalva maneuver to 10-20 cm H2O for 5 to 10 seconds. Up to two applications (one application includes applying up to two layers of Bioseal product followed by the CSF leakage re-evaluation with Valsalva maneuver) per subject are allowed. Closure of the remaining layers of the surgical site will be performed according to the surgeon's standard of practice.

Upon completion of the sutured dural repair, the closure will be evaluated for intra-operative CSF leakage with a baseline Valsalva maneuver to 10-20 cm H2O for 5-10 seconds. Subjects who have a CSF leak will be enrolled into the study. If randomized to receive Bioseal, a thin layer will be applied to the entire length of the suture line and the adjacent area to approximately 5mm away, including all suture holes. Up to two layers of Bioseal may be used for each application. While Bioseal achieves complete coagulation, CSF leakage will be re-evaluated with the Valsalva maneuver to 10-20 cm H2O for 5 to 10 seconds.

Bioseal

Ying Mao, MD, PhD

Richard Kocharian, MD, PhD

A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair

This is a randomized, single blinded, multi-center controlled study evaluating the effectiveness of Bioseal as an adjunct to sutured dural closure compared to control to obtain an intra-operative watertight dural closure.

Bioseal Dural Sealing Study BIOS-14-001

no CSF leakage from dural repair intra-operatively

Incidence of CSF leakage post-surgery to discharge

Incidence of CSF leakage 30 (±7) days post operatively

Incidence of surgical site infections (SSI) according to Surgical Site Infection Infection Prevention and Control Guideline (MOH) criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication	NCT00365989	Uterine Leiomyo... Uterine Fibroid...	ExAblate Enhanc...	18 Years -	InSightec
Bioseal Dural Sealing Study BIOS-14-001	NCT03110783	Benign Tumors Malignant Tumor... Vascular Malfor...	Bioseal	18 Years -	Guangzhou Bioseal Biotechnology Co., Ltd.
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication	NCT00365989	Uterine Leiomyo... Uterine Fibroid...	ExAblate Enhanc...	18 Years -	InSightec

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