Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380952
Status:
COMPLETED
Last Update Posted:
2008-05-28
First Post:
2006-09-26
Brief Title:
Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure
Sponsor:
Dune Medical Devices
Organization:
Dune Medical Devices
Study Overview
Official Title:
MAST Study Protocol
Status:
COMPLETED
Status Verified Date:
2008-05
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:
This protocol was designed for testing the intraoperative use of the Dune device This multicenter study will take place in Israel at 12 sites
Detailed Description:
Use of the device will take place during a partial mastectomy procedure lumpectomyThe patient will be randomized to enter the device or control arm
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