Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570785
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
IOPS Technology During Cannnulation of Contralateral Limb in EVAR
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Contralateral Limb Cannulation Using Intra-Operative Positioning SystemTechnology in Endovascular Aneurysm Repair
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:
IOPS
Brief Summary:
Short-term results are favorable for EndoVascular Aneurysm Repair EVAR compared to open surgery One of the major drawbacks to this shift is the need for fluoroscopy and contrast dyes to visualise endovascular devices The use of fluoroscopy exposes both patients and caregivers to harmful ionizing radiation Because of the harmful effects of radiation recent radiation protection guidelines strongly recommend as low as reasonably achievable ALARA principle The need for additional radiation-reducing navigation techniques is high with the ultimate goal of performing endovascular procedures without radiation at all
In response to these challenges Centerline Biomedical Cleveland Ohio USA has developed a proprietary electromagnetic tracking and positioning system called the Intra-Operative Positioning System IOPS This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the radiation exposure for patients and healthcare professionals IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy During the intervention the IOPS devices can be visualized with on-screen image guidance The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0035-inch catheters and guidewires as needed
This study aims to describe the influence of IOPS technology on radiation exposure during cannulation of the contralateral limb CL during standard EVAR
In response to these challenges Centerline Biomedical Cleveland Ohio USA has developed a proprietary electromagnetic tracking and positioning system called the Intra-Operative Positioning System IOPS This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the radiation exposure for patients and healthcare professionals IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy During the intervention the IOPS devices can be visualized with on-screen image guidance The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0035-inch catheters and guidewires as needed
This study aims to describe the influence of IOPS technology on radiation exposure during cannulation of the contralateral limb CL during standard EVAR
Detailed Description:
Background
The current standard of care for abdominal aortic aneurysm AAA is endovascular aneurysm repair EVAR which has been suggested as the treatment of choice by both European and American guidelines Although short-term results are favorable for EVAR compared to open surgery one of the major drawbacks to this shift is the need for fluoroscopy and contrast dyes to visualise endovascular devices The contrast dyes used during these procedures can induce renal failure in patients with preexisting renal dysfunction Meanwhile the use of fluoroscopy exposes both patients and caregivers to harmful ionizing radiation Because of the harmful effects of radiation recent radiation protection guidelines strongly recommend as low as reasonably achievable ALARA principle
In response to these challenges Centerline Biomedical Cleveland Ohio USA has developed a proprietary electromagnetic tracking and positioning system called the Intra-Operative Positioning System IOPS This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the use of contrast dye and radiation exposure for patients and healthcare professionals alike IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy Image guidance is provided using 3D maps of the vasculature generated from thin-slice contrast-enhanced preoperative computerised tomography angiography CTA At the start of the procedure a self-adhesive sterile fiducial tracking pad is attached to the patients lumbar region and the angiography system is used to perform a non-contrast-enhanced cone-beam CT scan The cone beam CT volume is then loaded onto the IOPS cart and manually aligned with the preoperative CT volume This work can be performed in parallel with achieving vascular access with minimal effects on the procedure time During the intervention the IOPS devices can be visualized with on-screen image guidance The console is operated by a technician under a physicians instruction The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0035-inch catheters and guidewires as needed This technology has been used by other centres for visceral and renal cannulation during complex aortic aneurysm procedures
Previously there have been publications on the use of Fiber Optic Real Shape FORS Technology with both complex and standard endovascular aneurysm repair EVAR showing the potential benefit of this technology in procedural time and radiation reduction However the need for additional radiation-reducing navigation techniques is high with the ultimate goal of performing endovascular procedures without radiation at all
This study aims to describe the influence of IOPS technology on radiation exposure during cannulation of the contralateral limb CL during standard EVAR
Study outcome and sample size
Technical success of using IOPS technology during cannulation of CL Navigation time expressed through total procedural time CL cannulation time fluoroscopy time overall and during CL cannulation Radiation exposure parameters that were described in the latest European Society for Vascular Surgery ESVS radiation guidelines cumulative air kerma CAK kerma area product KAP fluoroscopy time FT 4 To ensure sufficient statistical power to answer hypothetical questions 80 subjects will be entered into the database Navigation time and radiation exposure parameters are used to calculate the sample size Assuming the difference in terms of both parameters 30 patients are required in each arm to achieve a statistical power of 85 at p005 With two arms conventional and IOPS group assuming a 20 rate of missing data a total N of 80 patients is required
Research Design
This prospective study includes patients with standard AAA undergoing EVAR within instructions for use IFU treated from September 1st 2024 until May 1st 2025 at the Clinic for Vascular and Endovascular Surgery University Clinical Centre of Serbia
Procedures Involved
This study will not impact the care that patients receive Patient data will be compiled and analyzed to accomplish the proposed study objectives Data collection will include demographic information patient-related factors comorbidities diagnostic imaging information describing the morphology of the aortoiliac segment and periprocedural information related to the timing and radiation
Data management
After the data has been collected at a participating institution the data will be transmitted to an online database which will be available only to a central analytic center located at the Clinic for Vascular and Endovascular SurgeryUniversity Clinical Center of SerbiaMedical Faculty University of Belgrade
Risks to Subjects
As this is a prospective observational study performing EVAR in standard AAA using new radiation protection technology for visualisation of wires and catheters in a newly equipped angio suite there are minimal potential physical risks to subjects There is also a minimal risk of breach of confidentiality that could occur when patient information is collected and analyzed for the proposed study However appropriate measures will be taken to minimize the risk as much as possible All information recorded will be de-identified This study will abide by all regulations related to protecting human subjects and protected health information
Potential Benefits to Subjects
There is a potential benefit to the subjects involved in the IOPS group Hypothetically they will have lower procedural times and lower radiation doses during CL cannulation Future patients treated with this technology might have reduced radiation and cannulation times This will make it possible to perform more and more procedures with a minimal amount of radiation or even without radiation at all
Statistics and Data Analysis
Continuous variables will be described using the median and interquartile range or mean and standard deviation Categorical variables will be described using frequencies and percentages Group comparisons will be performed by using the Student t-test or Mann-Whitney U test as appropriate Categorical data will be expressed as percentages and will be compared using the chi-square test or Fisher exact test Differences will be considered statistically significant at p 005 Analyses will be performed using SPSS software version 280 SPSS Chicago ILLINOIS USA
Conflict of Interest
Since this is a physician-initiated trial the investigators have no conflict of interest to report
Funding Source
There are no plans to apply for additional grants or additional funding No funding is required for the completion of this study
Publication Plan
All research personnel included in this project will be eligible for authorship in any resulting abstracts and publications following the qualifications outlined by the International Committee of Medical Journal Editors The order of authors will be determined prior to manuscript development and depend on each individuals contribution to the study
The current standard of care for abdominal aortic aneurysm AAA is endovascular aneurysm repair EVAR which has been suggested as the treatment of choice by both European and American guidelines Although short-term results are favorable for EVAR compared to open surgery one of the major drawbacks to this shift is the need for fluoroscopy and contrast dyes to visualise endovascular devices The contrast dyes used during these procedures can induce renal failure in patients with preexisting renal dysfunction Meanwhile the use of fluoroscopy exposes both patients and caregivers to harmful ionizing radiation Because of the harmful effects of radiation recent radiation protection guidelines strongly recommend as low as reasonably achievable ALARA principle
In response to these challenges Centerline Biomedical Cleveland Ohio USA has developed a proprietary electromagnetic tracking and positioning system called the Intra-Operative Positioning System IOPS This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the use of contrast dye and radiation exposure for patients and healthcare professionals alike IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy Image guidance is provided using 3D maps of the vasculature generated from thin-slice contrast-enhanced preoperative computerised tomography angiography CTA At the start of the procedure a self-adhesive sterile fiducial tracking pad is attached to the patients lumbar region and the angiography system is used to perform a non-contrast-enhanced cone-beam CT scan The cone beam CT volume is then loaded onto the IOPS cart and manually aligned with the preoperative CT volume This work can be performed in parallel with achieving vascular access with minimal effects on the procedure time During the intervention the IOPS devices can be visualized with on-screen image guidance The console is operated by a technician under a physicians instruction The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0035-inch catheters and guidewires as needed This technology has been used by other centres for visceral and renal cannulation during complex aortic aneurysm procedures
Previously there have been publications on the use of Fiber Optic Real Shape FORS Technology with both complex and standard endovascular aneurysm repair EVAR showing the potential benefit of this technology in procedural time and radiation reduction However the need for additional radiation-reducing navigation techniques is high with the ultimate goal of performing endovascular procedures without radiation at all
This study aims to describe the influence of IOPS technology on radiation exposure during cannulation of the contralateral limb CL during standard EVAR
Study outcome and sample size
Technical success of using IOPS technology during cannulation of CL Navigation time expressed through total procedural time CL cannulation time fluoroscopy time overall and during CL cannulation Radiation exposure parameters that were described in the latest European Society for Vascular Surgery ESVS radiation guidelines cumulative air kerma CAK kerma area product KAP fluoroscopy time FT 4 To ensure sufficient statistical power to answer hypothetical questions 80 subjects will be entered into the database Navigation time and radiation exposure parameters are used to calculate the sample size Assuming the difference in terms of both parameters 30 patients are required in each arm to achieve a statistical power of 85 at p005 With two arms conventional and IOPS group assuming a 20 rate of missing data a total N of 80 patients is required
Research Design
This prospective study includes patients with standard AAA undergoing EVAR within instructions for use IFU treated from September 1st 2024 until May 1st 2025 at the Clinic for Vascular and Endovascular Surgery University Clinical Centre of Serbia
Procedures Involved
This study will not impact the care that patients receive Patient data will be compiled and analyzed to accomplish the proposed study objectives Data collection will include demographic information patient-related factors comorbidities diagnostic imaging information describing the morphology of the aortoiliac segment and periprocedural information related to the timing and radiation
Data management
After the data has been collected at a participating institution the data will be transmitted to an online database which will be available only to a central analytic center located at the Clinic for Vascular and Endovascular SurgeryUniversity Clinical Center of SerbiaMedical Faculty University of Belgrade
Risks to Subjects
As this is a prospective observational study performing EVAR in standard AAA using new radiation protection technology for visualisation of wires and catheters in a newly equipped angio suite there are minimal potential physical risks to subjects There is also a minimal risk of breach of confidentiality that could occur when patient information is collected and analyzed for the proposed study However appropriate measures will be taken to minimize the risk as much as possible All information recorded will be de-identified This study will abide by all regulations related to protecting human subjects and protected health information
Potential Benefits to Subjects
There is a potential benefit to the subjects involved in the IOPS group Hypothetically they will have lower procedural times and lower radiation doses during CL cannulation Future patients treated with this technology might have reduced radiation and cannulation times This will make it possible to perform more and more procedures with a minimal amount of radiation or even without radiation at all
Statistics and Data Analysis
Continuous variables will be described using the median and interquartile range or mean and standard deviation Categorical variables will be described using frequencies and percentages Group comparisons will be performed by using the Student t-test or Mann-Whitney U test as appropriate Categorical data will be expressed as percentages and will be compared using the chi-square test or Fisher exact test Differences will be considered statistically significant at p 005 Analyses will be performed using SPSS software version 280 SPSS Chicago ILLINOIS USA
Conflict of Interest
Since this is a physician-initiated trial the investigators have no conflict of interest to report
Funding Source
There are no plans to apply for additional grants or additional funding No funding is required for the completion of this study
Publication Plan
All research personnel included in this project will be eligible for authorship in any resulting abstracts and publications following the qualifications outlined by the International Committee of Medical Journal Editors The order of authors will be determined prior to manuscript development and depend on each individuals contribution to the study
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