Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569706
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
NEOMAMENDO
Brief Summary:
Nipple -Sparing Mastectomy NSM with immediate breast reconstruction IBR can be offered to patients requiring mastectomy when the lesion is more than 2cm from the nipple Endoscopic mastectomy is a technical alternative for small-volume breasts cup sizes A B C offering a NSM with IBR but also concealing the scar on the axillary line It can be performed with traditional laparoscopic equipment making this technique much more accessible and less costly than robotic mastectomy It uses a single-port device that is significantly less costly than robotic equipment
Feasibility and safety studies remain limited to the Asian continent and it would undoubtedly be beneficial to initiate research in Europe to add this new technical option to our surgical arsenal This study project aims to explore the feasibility and safety of endoscopic nipple-sparing mastectomy for breast cancer indications in a French center
Feasibility and safety studies remain limited to the Asian continent and it would undoubtedly be beneficial to initiate research in Europe to add this new technical option to our surgical arsenal This study project aims to explore the feasibility and safety of endoscopic nipple-sparing mastectomy for breast cancer indications in a French center
Detailed Description:
It s a practicability study evaluating endoscopic approach for mastectomy using an axillary single port in breast cancer patients Conventional surgery conversion rate operative time infectious rate esthetical outcomes oncological safety and functional outcomes will be evaluated
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