Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166270
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2005-09-09
Brief Title:
MR Guided Focused Ultrasound Surgery in the Treatment 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:
2018-07
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:
This is a prospective nonrandomized multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms
Detailed Description:
After the PMA Panel the sponsor was requested to conduct a post-approval study The objective of this study is to gather additional data to evaluate the safety and long term effectiveness of focused ultrasound treatment and to include a larger cohort of African-American patients Patients will be treated following the approved commercial treatment guidelines
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
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
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