Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572410
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
Status:
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:
None
Brief Summary:
Observational study The purpose of this study is to evaluate the use of real-time surgical navigation for the localization and surgical removal of soft tissue tumors The goal is to collect information about the efficiency and effectiveness of the EnVisio Surgical Navigation for intraoperative guidance to obtain negative margin on initial specimen
Prospective Patient Study 200 consecutive patients
Prospective Patient Study 200 consecutive patients
Detailed Description:
Objectives
1 To collect data throughout clinical patient workflow for evaluation of
1 localization with SmartClips
2 negative margin on primary specimen
3 specimen assessment
4 length of operation
The EnVisio Navigation System was cleared as a Class II device by the FDA under 510k number K183400 The SmartClip Soft Tissue Marker was cleared by the FDA under 510k number K180640
Principal Investigator will receive monthly EnVisio system data from Company representative on the EnVisio system data collection for procedural cross reference resulting in
Date
Time of SmartClips auto detection
Color and Number of SmartClips
Total time of EnVisio Guidance
Specimen Assessment recordings of SmartClip to specimen edge as recorded by electrocautery tip on identified margin MedialLateralSuperiorInferiorAnteriorPosterior
Data will be collected from procedures performed including all imaging clinical and pathologic outcomes Pre and Post procedure data including number of individual lesions localization of mass and number of SmartClips used Patients planning surgical excision of an imaging identifiable in-breast will be offered entry into this study the AdventHealth Winter Garden location will provide standard informed consent form for the purposes of this study The projected accrual for this study is 200 patients in total
1 To collect data throughout clinical patient workflow for evaluation of
1 localization with SmartClips
2 negative margin on primary specimen
3 specimen assessment
4 length of operation
The EnVisio Navigation System was cleared as a Class II device by the FDA under 510k number K183400 The SmartClip Soft Tissue Marker was cleared by the FDA under 510k number K180640
Principal Investigator will receive monthly EnVisio system data from Company representative on the EnVisio system data collection for procedural cross reference resulting in
Date
Time of SmartClips auto detection
Color and Number of SmartClips
Total time of EnVisio Guidance
Specimen Assessment recordings of SmartClip to specimen edge as recorded by electrocautery tip on identified margin MedialLateralSuperiorInferiorAnteriorPosterior
Data will be collected from procedures performed including all imaging clinical and pathologic outcomes Pre and Post procedure data including number of individual lesions localization of mass and number of SmartClips used Patients planning surgical excision of an imaging identifiable in-breast will be offered entry into this study the AdventHealth Winter Garden location will provide standard informed consent form for the purposes of this study The projected accrual for this study is 200 patients in total
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