Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512558
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
AR-GBS
Brief Summary:
Breast cancer is diagnosed by imaging at a non-palpable stage in more than half of all cases Surgical removal requires preoperative guidance Generally preoperative guidance is performed using a metal guide under local anaesthetic and radiological control This type of guidance has several limitations For the patient it can be painful and traumatic The procedure involves two departments radiology and the operating theatre which poses logistical constraints Whats more between 10 and 40 of patients require repeat surgery for unhealthy margins raising the question of the effectiveness of the tracking procedure The investigators propose to develop a non-invasive intraoperative guidance system Augmented Reality which will provide a 3D vision with virtual transparency of the breast during surgery thanks to real-time fusion of preoperative imaging with video from a camera located in the operating room The process is illustrated below
Illustration of the general principle of the augmented reality system for locating non-palpable breast lesions The images above represent a preliminary test carried out on the computer outside the operating room This is an initial research prototype which has not yet been validated and is not suitable for routine use
Illustration of the general principle of the augmented reality system for locating non-palpable breast lesions The images above represent a preliminary test carried out on the computer outside the operating room This is an initial research prototype which has not yet been validated and is not suitable for routine use
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