Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131365
Status:
COMPLETED
Last Update Posted:
2019-06-12
First Post:
2005-08-17
Brief Title:
Magnetic Resonance MR Guided Focused Ultrasound Surgery of Uterine Fibroids
Sponsor:
InSightec
Organization:
InSightec
Study Overview
Official Title:
Post Approval Study MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Background
General
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 In general these symptoms can be classified into two categories
1 heavy menstrual bleeding defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less significant clot passage flooding substantial prolongation of menstrual periods compared with the patients prior experience or anemia
2 pelvic pain or pressure heaviness or discomfort or similar symptoms in the back flank or leg attributable to the bulk of the fibroid urinary frequency increase in nocturia difficulty voiding or compression of the ureters with hydronephrosis
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment decrease in pain bladder or bowel symptoms or reduction in vaginal bleeding while experiencing a minimum of co-morbidities from the treatment itself
ExAblate Device
The InSightec ExAblate MR guided Focused Ultrasound Surgery MRgFUS system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue It has been evaluated in an earlier FDA international multi-center study and found to be safe and effective for the treatment of uterine fibroids ExAblate device received FDA approval in October 2004
Prior Studies
The ExAblate has been used for the treatment of uterine fibroids in 2 previous IDE protocols
Group A This was the original Pivotal Study Group IDE G020001 - Protocol UF002 These 109 patients were treated at 3 sites in the US and at 4 sites outside the US There was a limitation on the allowable treatment volume and only a single treatment was permitted Original follow-up was planned for 6 months The study was later extended to include follow-up visits at 12 24 and 36 months UF009 Because of the gap between the initial study consent and the re-consent for the long term follow-up there was a high dropout rate at the 12 month visit Thirty-three US patients returned for the 12 months visit and will continue to be followed for the 24 and 36 M visits
Group B This was the Continued Access Study IDE G020001 - Protocol UF005 where approximately 160 patients were treated at 3 sites in the US during the PMA review period Treatment conditions were modified somewhat from the pivotal including the addition of a second treatment session where necessary The initial study was planned to include a long term follow-up of 12 24 and 36 months UF009
Group C This group of 70 patients UF14 will be treated post-PMA approval following the commercial treatment guidelines The follow-up will include for visits at 12 24 and 36 months This group includes also another 20 patients who will be treated under this original IDE to validate the ExAblate system for use in a 3T MR scanner as well as validating a new application SW V41
General
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 In general these symptoms can be classified into two categories
1 heavy menstrual bleeding defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less significant clot passage flooding substantial prolongation of menstrual periods compared with the patients prior experience or anemia
2 pelvic pain or pressure heaviness or discomfort or similar symptoms in the back flank or leg attributable to the bulk of the fibroid urinary frequency increase in nocturia difficulty voiding or compression of the ureters with hydronephrosis
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment decrease in pain bladder or bowel symptoms or reduction in vaginal bleeding while experiencing a minimum of co-morbidities from the treatment itself
ExAblate Device
The InSightec ExAblate MR guided Focused Ultrasound Surgery MRgFUS system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue It has been evaluated in an earlier FDA international multi-center study and found to be safe and effective for the treatment of uterine fibroids ExAblate device received FDA approval in October 2004
Prior Studies
The ExAblate has been used for the treatment of uterine fibroids in 2 previous IDE protocols
Group A This was the original Pivotal Study Group IDE G020001 - Protocol UF002 These 109 patients were treated at 3 sites in the US and at 4 sites outside the US There was a limitation on the allowable treatment volume and only a single treatment was permitted Original follow-up was planned for 6 months The study was later extended to include follow-up visits at 12 24 and 36 months UF009 Because of the gap between the initial study consent and the re-consent for the long term follow-up there was a high dropout rate at the 12 month visit Thirty-three US patients returned for the 12 months visit and will continue to be followed for the 24 and 36 M visits
Group B This was the Continued Access Study IDE G020001 - Protocol UF005 where approximately 160 patients were treated at 3 sites in the US during the PMA review period Treatment conditions were modified somewhat from the pivotal including the addition of a second treatment session where necessary The initial study was planned to include a long term follow-up of 12 24 and 36 months UF009
Group C This group of 70 patients UF14 will be treated post-PMA approval following the commercial treatment guidelines The follow-up will include for visits at 12 24 and 36 months This group includes also another 20 patients who will be treated under this original IDE to validate the ExAblate system for use in a 3T MR scanner as well as validating a new application SW V41
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None