MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ExAblate Enhanced Sonication

About this trial

This is an interventional treatment trial for Uterine Leiomyoma focused on measuring Fibroids, leiomyoma, neoplasm, benign tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women age 18 or older, who present with symptomatic fibroids Women who have given written informed consent Women who are able and willing 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 Criteria: Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment Patient who desire to become pregnant in the future. Patients who are breast-feeding. Patients with an active pelvic inflammatory disease (PID) Active local or systemic infection Metallic implants that are incompatible with MRI Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) Severe claustrophobia that would prevent completion of procedure in the MR unit. Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia. Pedunculated fibroids. Intrauterine device (IUD) anywhere in the treatment path Undiagnosed vaginal bleeding.

Sites / Locations

University of California at San Diego
Lahey Clinic
KNI
Cornell Vascular
Toronto General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ExAblate Enhanced Sonication Test Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00365989

First Posted

August 17, 2006

Last Updated

February 4, 2019

Sponsor

InSightec

1. Study Identification

Unique Protocol Identification Number

NCT00365989

Brief Title

MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InSightec

4. Oversight

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Leiomyoma, Uterine Fibroids

Keywords

Fibroids, leiomyoma, neoplasm, benign tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ExAblate Enhanced Sonication Test Arm

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

ExAblate Enhanced Sonication

Other Intervention Name(s)

Magnetic Resonance guided Focused Ultrasound

Primary Outcome Measure Information:

Title

Number of Adverse Events

Description

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

Other Pre-specified Outcome Measures:

Title

Mean Enhanced Sonication Normalized Thermal Dose Volume

Description

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

Title

Number of Participants With Adverse Events

Time Frame

Within 1 month of treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women age 18 or older, who present with symptomatic fibroids Women who have given written informed consent Women who are able and willing 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 Criteria: Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment Patient who desire to become pregnant in the future. Patients who are breast-feeding. Patients with an active pelvic inflammatory disease (PID) Active local or systemic infection Metallic implants that are incompatible with MRI Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) Severe claustrophobia that would prevent completion of procedure in the MR unit. Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia. Pedunculated fibroids. Intrauterine device (IUD) anywhere in the treatment path Undiagnosed vaginal bleeding.

Overall Study Officials: