Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295217
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2006-02-21
Brief Title:
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids Software V42 Validation
Sponsor:
InSightec
Organization:
InSightec
Study Overview
Official Title:
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids Clinical Study to Validate the Changes to ExAblate 2000 Device
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to validate the new ExAblate Application software V42 by developing additional data that shows the safety of this treatment 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:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Continued Access | None | None | None |