Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638125
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
3-Dimensional Virtual Reality Modelling With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
3-Dimensional Virtual Reality Modelling With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
With the advent of CT screening for lung cancer an increasing number of NSCLCs are being detected at very early stages and the demand for pulmonary segmentectomy is rising rapidly As such there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer or for patients unable to undergo a full lobectomy due to existing comorbidities This study will provide the first case series using preoperative 3D virtual reality VR anatomical planning Elucis added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Elucis-guided targeted pulmonary segmental resection in Canada As lung cancer is the most frequently fatal cancer in North America many thousands of patients will be able to benefit from this operation every year
If successful this project will establish a novel operation that has the potential of increasing the rates of success for segmental resection This will allow for further research that will externally validate this technique and ensure that it is reproducible in other centres by other surgeons As segmental resection is the new standard of care for surgical management of early-stage NSCLC and because lung cancer is the most frequently fatal cancer in North America many thousands of patients will be able to benefit from this operation every year
Equally importantly the investigators believe that this method will enable them to develop a new way of teaching lung resections in a manner that is more effective for learners Further research on the role of VR in teaching lung cancer surgery will very likely be a downstream effect of developing this surgical method
If successful this project will establish a novel operation that has the potential of increasing the rates of success for segmental resection This will allow for further research that will externally validate this technique and ensure that it is reproducible in other centres by other surgeons As segmental resection is the new standard of care for surgical management of early-stage NSCLC and because lung cancer is the most frequently fatal cancer in North America many thousands of patients will be able to benefit from this operation every year
Equally importantly the investigators believe that this method will enable them to develop a new way of teaching lung resections in a manner that is more effective for learners Further research on the role of VR in teaching lung cancer surgery will very likely be a downstream effect of developing this surgical method
Detailed Description:
Segmental resection is the new standard of care for early-stage non-small cell lung cancer NSCLC However minimally invasive segmental resection is very difficult to perform due to high inconsistency and variation in segmental anatomy and the lack of clearly visible tissue planes between segments intersegmental planes The investigators have demonstrated that the rate of successful completion of a segmental resection is only 60 As such segmental resections are unlikely to become widely adopted by surgeons outside of centres of high volume expertise unless an adjunct to facilitate and improve the success rate of this operation is developed In this trial the investigators propose to use 3-dimensional 3D virtual reality VR modelling to plan simulate and execute segmental resections The investigators believe that this adjunct will improve the rate of successful completion of this operation
This submission proposes a novel operation for segmental resections of the lung Segmental resections are extremely difficult to perform because of the high rate of anatomical variations in segmental anatomy and the lack of visible tissue planes between segments In the largest prospective series on segmental resection the investigators demonstrated that the rate of completion was only 60 The investigators therefore conducted a subsequent trial utilizing 3D preoperative anatomical planning Synapse 3D in conjunction with intraoperative NIF-mapping using intravascular ICG in order to increase the rate of successful completion of a segmental resection However planned interim analyses has shown that there is no difference in the rate of successful completion of a segmental resection using Synapse 3D or NIF This is likely the case because the investigators are using 2D models to plan a 3D operation In this submission the investigators hypothesize that adding 3D VR preoperative anatomical planning Elucis to NIF-guided segmental resection can greatly increase the rate of success of segmental resections In this Phase I trial the investigators propose to describe the technical details of this novel operation and to evaluate it for safety feasibility and learning curve If successful this would be the first trial to do so and would allow for further Phase II and III comparative trials to evaluate this operation
This submission proposes a novel operation for segmental resections of the lung Segmental resections are extremely difficult to perform because of the high rate of anatomical variations in segmental anatomy and the lack of visible tissue planes between segments In the largest prospective series on segmental resection the investigators demonstrated that the rate of completion was only 60 The investigators therefore conducted a subsequent trial utilizing 3D preoperative anatomical planning Synapse 3D in conjunction with intraoperative NIF-mapping using intravascular ICG in order to increase the rate of successful completion of a segmental resection However planned interim analyses has shown that there is no difference in the rate of successful completion of a segmental resection using Synapse 3D or NIF This is likely the case because the investigators are using 2D models to plan a 3D operation In this submission the investigators hypothesize that adding 3D VR preoperative anatomical planning Elucis to NIF-guided segmental resection can greatly increase the rate of success of segmental resections In this Phase I trial the investigators propose to describe the technical details of this novel operation and to evaluate it for safety feasibility and learning curve If successful this would be the first trial to do so and would allow for further Phase II and III comparative trials to evaluate this operation
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