Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920317
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2022-03-02
Brief Title:
Comparison of a Full Automatic Software With Standard Methods of Vessels Analysis
Sponsor:
Nurea
Organization:
Nurea
Study Overview
Official Title:
Retrospective Study of the Use of PRAEVAorta 2 Software for Vessel Geometric Analysis Versus Standard Analysis Methods in Patients With Abdominal Aortic Aneurysm
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRAEVA-2-LP
Brief Summary:
The treatment of aortic aneurysms is today based on different indicators diameters lengths angles volumes of the arteries measured on CT scan images Several indicators are time consuming and complicatated to measure They demand training and practice Nurea is developing a software for automatic measurement of these indicators PRAEVAorta 2 to facilitate and assist the physician in his clinical routine
The purpose of this study is to compare the analysis realised by the software PRAEVAorta 2 with the analysis realised by the healthcare professional on retrospective CT scan images
Contrasted and non-contrasted pre-operation or post-operation CT scans from 50 patients will be analysed
The main objectif is to validate the accuracy of the software by demonstrating its adequacy to the standard method of analysis
The second objectives are the following
Evaluate the security of the software PRAEVAorta 2
Evaluate the unanticipated risks related to the use of the software
Validate the accessory PRAEVAorta Web
We make the following assumption
90 of the patients show 90 of adequacy to the healthcare professional analysis
The purpose of this study is to compare the analysis realised by the software PRAEVAorta 2 with the analysis realised by the healthcare professional on retrospective CT scan images
Contrasted and non-contrasted pre-operation or post-operation CT scans from 50 patients will be analysed
The main objectif is to validate the accuracy of the software by demonstrating its adequacy to the standard method of analysis
The second objectives are the following
Evaluate the security of the software PRAEVAorta 2
Evaluate the unanticipated risks related to the use of the software
Validate the accessory PRAEVAorta Web
We make the following assumption
90 of the patients show 90 of adequacy to the healthcare professional analysis
Detailed Description:
The study PRAEVA-2-LP is realized in the University hospital of Leipzig The treatment of aortic aneurysms is today based on different indicators diameters lengths angles volumes of the arteries measured on CT scan images Several indicators are time consuming and complicatated to measure They demand training and practice Nurea is developing a software for automatic measurement of these indicators PRAEVAorta 2 to facilitate and assist the physician in his clinical routine
The purpose of this study is to compare the analysis realised by the software PRAEVAorta 2 with the analysis realised by the healthcare professional on retrospective CT scan images
Contrasted and non-contrasted pre-operation or post-operation CT scans from 50 patients will be analysed
We make the following assumption 90 of the patients show 90 of adequacy to the healthcare professional analysis
This study is comparative retrospective non-interventional and monocentric We compare the SaMD measurements to measurements realised using the standard method by a healthcare professional The study analysis retrospective pseudonymised CT scans and deliver aggregated data The study will be realised on a group of 50 subjects which is small enough to have one site of investigation Subjects will be their own witness This strategy allows us to minimize the cost and the risks of the study without compromising the investigation This investigation is submitted to the local ethics committee for approval according to paragraph 15 of Professional Code of the Saxon State Medical Association Berufsordnung - BO of 24 June 1998
The study realised on the first version of the medical device PRAEVAorta has shown a proportion of 93 of patient with measures calculated by the software in adequation with the measures realised following the standard method of analysis ratio 90 Because the new version of the software PRAEVAorta2 has been improved we expect to observe the same proportion
Patient number calculation
Hypotheses are the following
H0 The proportion of patients with an absolute mean discrepancy 5mm is 90 H1 The proportion of patient with an absolute mean discrepancy 5mm is strictly over 90 For this statistical analysis variables are quantitative aorta measurements We consider over here the proportion of patients per sub-group who have as less or greater than 90
Comparison of two proportions a theoretical proportion with an observed proportion The theoretical proportion ϕ0 is 90 The observed proportion ϕ is 93 the observed proportion in the study of PRAEVAorta 1 Therefore the numbers of patients needed with an α risk of 5 and a β risk of 09 is 32 in unilateral n196φ01-φ005 u2βφ1-φ052φ0-φ232 For security reasons and to anticipate any problem we choose to include approximately 10 more subjects Moreover to be sure that the amount of data is sufficient for CE marking we add another 15 Therefore the total of patient is 50
The collected data comes from a database built by the hospital especially for retrospective study The patient consent has already been collected at the creation of the database which exempt us from collecting it again
The collected data are the gender the birthdate of the patient the scan manufacturer the contrast-enhanced CT scan the date of realization of the CT scan the indicators the healthcare professional trust in the results of the analysis realized by the software
Images analysis Pseudonymised images in DICOM format will be analysed Pre-operation and post-operation thin-sliced CT images will be analysed
Procedure to follow
1 Inclusion and exclusion criteria validation
2 Demographic data and scanner references collection
3 CT scans in DICOM format collection
4 First Randomisation of the subjects order
5 Determination of the measures by the physician with the standard method
6 Second randomisation of the subjects order
7 Software analysis of the images with PRAEVAorta 2 and Physician trust opinion In step 7 physicians will have to indicate if based on the report generated by PRAEVAorta 2 they trust the software measures or they do not in order to validate clinical safety
The comparison of data will be done during the statistical analysis
The data will be collected in an EDC e-CRF The software allow authentication account management with several level of access to the different parts and data Exchanges are secured and data are stored on a Health Data Host accredited server A back-up is regularly made
The practician fills a form report when measuring the indicators and the software PRAEVAorta 2 is returning a pdf report The data collected in the EDC will be compared with the data present in those two reports and in the hospital study database
Most monitoring will be realised in remote A monitoring visit will be realised at mid-time A data review and validation will be realised before database lockdown Data will then be validated by the PI and the data manager
Data management
Data collected are pseudonymised to ensure confidentiality and medical secret and registered in the e-CRF
Demographic data as well as scans are available in the hospitals database set up specifically for retrospective data studies Measures realised on the CT scans are registered on an electronic report for both measurements methods The data from those reports and from the database are reported in the e-CRF Analysed CT scans are also uploaded in the e-CRF
Data cannot be registered in the software before the subjects inclusion has been validated
Data entered into the software must be double-checked to limit errors
Data validation
This requirement is achieved through Source Data Verification the process by which the information reported on the e-CRF by the investigator is compared with the original medical records to ensure it is complete and accurate during monitoring visits and closure visit
In addition a system of dynamic consistency checks is implemented in the e-CRF for rapid data validation when applicable
Through the Source Data Validation process the monitor should confirm accurate transcription of data from source files to the CRF and that the CRF contains all the relevant information about the patients participation in the clinical trial
Monitoring visit process
Process
The first monitoring visit will be conducted after the completion of the Step 4 of the procedure has been completed to review first part of data The rest will be reviewed in close-out visit
Monitoring call and conference will be realized at the end of each step and when required The Monitoring visit will review all of the responsibilities listed above Following each monitoring visit call a monitoring report will be submitted to the QI
The following activities may take place during each monitoring visit
The following participant data will be source data verified for the indicated percentage of participants enrolled in the trial and all incidences reported since the last monitoring visit
100 of eligibility criteria 100 of participant CRFs
Any updates andor revisions to the following study documents since the last monitoring visit will also be reviewed
Training documentationrecords and Task Delegation Log updates Regulatory documentation including Health Canada approvalamendments
The following activities may be conducted at each monitoring visit
Trial Master File
Ensure that essential document files are complete and current
Investigator and Site Personnel Responsibilities
Ensure that the Task Delegation Log is complete and signed
Verify that the QI and site personnel are adhering to the protocol and conducting the study according to regulatory requirements Procedures and NF ISO 141552020
Verify that study activities are being performed by the QI or have been delegated to personnel qualified by appropriate education and training
Provide and document any necessary training for the QI and site personnel such as training on NF ISO 141552020 procedures protocol e-CRF
CRF Review Source Documentation Verification Verify the following
Accurate complete and current source documentation is maintained
Participants eligibility reviewed and signed off by QISub-Investigator
All procedures outlined in the protocol were completed
Protocol deviations documented and reported according to the protocol
All dropouts of enrolled subjects are recorded in the source documentation and on the CRF
The QI has reviewed signed and dated all required e-CRF pages in a timely manner
Data entries in the e-CRF pages coincide with the source documentation and note any errors omissions or discrepancies by issuing queries within the e-CRF system and revise other bullets
Provide the site staff with copies of Data correction forms
Verify that previously outstanding data queries have been resolved signed and dated by the QI or designee
Device Deficiency DD
Verify all newly reported DDs against source documentation
Follow up on previously reported DDs
Confirm that all DDs have been reported to the Sponsor
Identify any unreported DDs in source documentation
Review DDs reporting procedures as necessary
Protocol Deviations
Verify that all protocol deviations are documented appropriately in each participants research record and on the appropriate protocol deviation form
Ensure that the site has reported all protocol deviations to the Ethical Committee as defined by EC policy andor procedures
Address any protocol deviations with site personnel during the monitoring visit and identify ways to prevent a recurrence of similar issues
General
Confirm all data is verifiable against source documentation
Confirm no transcription errors have been made
Ensure corrections are lined out dated initialed no erasures or whiteouts
Visit Conclusion
At the conclusion of the visit the monitor will meet with the QI and site research staff to review visit findings and answer questions The monitor will discuss the following topics at a minimum
Enrolment progress
Study conducts and documentation of study activities
Deviations
Scheduling of the next Monitoring Visit when applicable
Statistics
Aggregated data analysed as treated and per subgroup Descriptive analysis
Pearsons coefficient correlation
Absolute mean discrepancy per measurements
Global mean and standard deviation per measurement endpoint
Ratio for a measure
Maximum aortic diameter ratio
Computational analysis time The duration of the semi-automatic segmentation manually corrected by the 2 surgeons was reported and compared to the fully automatic method
Detectable and non-detectable error rate for safety evaluation
Calculation of false positive false negative sensibility specificity positive predictive values negative predictive values and likelihood ratio LR and LR-
Inferential analysis Objective comparing an observed proportion p1 with a theoretical proportion p0 p1 proportion of adequate data p0 theoretical proportion 90
A one-sided right test will be realised to evaluate the comparison
Evaluation criteria
Principal criteria
90 of the patients shaw 90 of adequacy
Secondary criteria
Evaluation of the measurements and the segmentations
The mean discrepancy shall be 5mm
Pearson correlation shall be 90
Evaluation of risks
Unanticipated risks should not be critical Evaluation of the security
The detectable error rate shall be 95
The non-detectable error rate shall be 5 Evaluation of PRAEVAorta Web
No critical bug No critical unanticipated risks
The purpose of this study is to compare the analysis realised by the software PRAEVAorta 2 with the analysis realised by the healthcare professional on retrospective CT scan images
Contrasted and non-contrasted pre-operation or post-operation CT scans from 50 patients will be analysed
We make the following assumption 90 of the patients show 90 of adequacy to the healthcare professional analysis
This study is comparative retrospective non-interventional and monocentric We compare the SaMD measurements to measurements realised using the standard method by a healthcare professional The study analysis retrospective pseudonymised CT scans and deliver aggregated data The study will be realised on a group of 50 subjects which is small enough to have one site of investigation Subjects will be their own witness This strategy allows us to minimize the cost and the risks of the study without compromising the investigation This investigation is submitted to the local ethics committee for approval according to paragraph 15 of Professional Code of the Saxon State Medical Association Berufsordnung - BO of 24 June 1998
The study realised on the first version of the medical device PRAEVAorta has shown a proportion of 93 of patient with measures calculated by the software in adequation with the measures realised following the standard method of analysis ratio 90 Because the new version of the software PRAEVAorta2 has been improved we expect to observe the same proportion
Patient number calculation
Hypotheses are the following
H0 The proportion of patients with an absolute mean discrepancy 5mm is 90 H1 The proportion of patient with an absolute mean discrepancy 5mm is strictly over 90 For this statistical analysis variables are quantitative aorta measurements We consider over here the proportion of patients per sub-group who have as less or greater than 90
Comparison of two proportions a theoretical proportion with an observed proportion The theoretical proportion ϕ0 is 90 The observed proportion ϕ is 93 the observed proportion in the study of PRAEVAorta 1 Therefore the numbers of patients needed with an α risk of 5 and a β risk of 09 is 32 in unilateral n196φ01-φ005 u2βφ1-φ052φ0-φ232 For security reasons and to anticipate any problem we choose to include approximately 10 more subjects Moreover to be sure that the amount of data is sufficient for CE marking we add another 15 Therefore the total of patient is 50
The collected data comes from a database built by the hospital especially for retrospective study The patient consent has already been collected at the creation of the database which exempt us from collecting it again
The collected data are the gender the birthdate of the patient the scan manufacturer the contrast-enhanced CT scan the date of realization of the CT scan the indicators the healthcare professional trust in the results of the analysis realized by the software
Images analysis Pseudonymised images in DICOM format will be analysed Pre-operation and post-operation thin-sliced CT images will be analysed
Procedure to follow
1 Inclusion and exclusion criteria validation
2 Demographic data and scanner references collection
3 CT scans in DICOM format collection
4 First Randomisation of the subjects order
5 Determination of the measures by the physician with the standard method
6 Second randomisation of the subjects order
7 Software analysis of the images with PRAEVAorta 2 and Physician trust opinion In step 7 physicians will have to indicate if based on the report generated by PRAEVAorta 2 they trust the software measures or they do not in order to validate clinical safety
The comparison of data will be done during the statistical analysis
The data will be collected in an EDC e-CRF The software allow authentication account management with several level of access to the different parts and data Exchanges are secured and data are stored on a Health Data Host accredited server A back-up is regularly made
The practician fills a form report when measuring the indicators and the software PRAEVAorta 2 is returning a pdf report The data collected in the EDC will be compared with the data present in those two reports and in the hospital study database
Most monitoring will be realised in remote A monitoring visit will be realised at mid-time A data review and validation will be realised before database lockdown Data will then be validated by the PI and the data manager
Data management
Data collected are pseudonymised to ensure confidentiality and medical secret and registered in the e-CRF
Demographic data as well as scans are available in the hospitals database set up specifically for retrospective data studies Measures realised on the CT scans are registered on an electronic report for both measurements methods The data from those reports and from the database are reported in the e-CRF Analysed CT scans are also uploaded in the e-CRF
Data cannot be registered in the software before the subjects inclusion has been validated
Data entered into the software must be double-checked to limit errors
Data validation
This requirement is achieved through Source Data Verification the process by which the information reported on the e-CRF by the investigator is compared with the original medical records to ensure it is complete and accurate during monitoring visits and closure visit
In addition a system of dynamic consistency checks is implemented in the e-CRF for rapid data validation when applicable
Through the Source Data Validation process the monitor should confirm accurate transcription of data from source files to the CRF and that the CRF contains all the relevant information about the patients participation in the clinical trial
Monitoring visit process
Process
The first monitoring visit will be conducted after the completion of the Step 4 of the procedure has been completed to review first part of data The rest will be reviewed in close-out visit
Monitoring call and conference will be realized at the end of each step and when required The Monitoring visit will review all of the responsibilities listed above Following each monitoring visit call a monitoring report will be submitted to the QI
The following activities may take place during each monitoring visit
The following participant data will be source data verified for the indicated percentage of participants enrolled in the trial and all incidences reported since the last monitoring visit
100 of eligibility criteria 100 of participant CRFs
Any updates andor revisions to the following study documents since the last monitoring visit will also be reviewed
Training documentationrecords and Task Delegation Log updates Regulatory documentation including Health Canada approvalamendments
The following activities may be conducted at each monitoring visit
Trial Master File
Ensure that essential document files are complete and current
Investigator and Site Personnel Responsibilities
Ensure that the Task Delegation Log is complete and signed
Verify that the QI and site personnel are adhering to the protocol and conducting the study according to regulatory requirements Procedures and NF ISO 141552020
Verify that study activities are being performed by the QI or have been delegated to personnel qualified by appropriate education and training
Provide and document any necessary training for the QI and site personnel such as training on NF ISO 141552020 procedures protocol e-CRF
CRF Review Source Documentation Verification Verify the following
Accurate complete and current source documentation is maintained
Participants eligibility reviewed and signed off by QISub-Investigator
All procedures outlined in the protocol were completed
Protocol deviations documented and reported according to the protocol
All dropouts of enrolled subjects are recorded in the source documentation and on the CRF
The QI has reviewed signed and dated all required e-CRF pages in a timely manner
Data entries in the e-CRF pages coincide with the source documentation and note any errors omissions or discrepancies by issuing queries within the e-CRF system and revise other bullets
Provide the site staff with copies of Data correction forms
Verify that previously outstanding data queries have been resolved signed and dated by the QI or designee
Device Deficiency DD
Verify all newly reported DDs against source documentation
Follow up on previously reported DDs
Confirm that all DDs have been reported to the Sponsor
Identify any unreported DDs in source documentation
Review DDs reporting procedures as necessary
Protocol Deviations
Verify that all protocol deviations are documented appropriately in each participants research record and on the appropriate protocol deviation form
Ensure that the site has reported all protocol deviations to the Ethical Committee as defined by EC policy andor procedures
Address any protocol deviations with site personnel during the monitoring visit and identify ways to prevent a recurrence of similar issues
General
Confirm all data is verifiable against source documentation
Confirm no transcription errors have been made
Ensure corrections are lined out dated initialed no erasures or whiteouts
Visit Conclusion
At the conclusion of the visit the monitor will meet with the QI and site research staff to review visit findings and answer questions The monitor will discuss the following topics at a minimum
Enrolment progress
Study conducts and documentation of study activities
Deviations
Scheduling of the next Monitoring Visit when applicable
Statistics
Aggregated data analysed as treated and per subgroup Descriptive analysis
Pearsons coefficient correlation
Absolute mean discrepancy per measurements
Global mean and standard deviation per measurement endpoint
Ratio for a measure
Maximum aortic diameter ratio
Computational analysis time The duration of the semi-automatic segmentation manually corrected by the 2 surgeons was reported and compared to the fully automatic method
Detectable and non-detectable error rate for safety evaluation
Calculation of false positive false negative sensibility specificity positive predictive values negative predictive values and likelihood ratio LR and LR-
Inferential analysis Objective comparing an observed proportion p1 with a theoretical proportion p0 p1 proportion of adequate data p0 theoretical proportion 90
A one-sided right test will be realised to evaluate the comparison
Evaluation criteria
Principal criteria
90 of the patients shaw 90 of adequacy
Secondary criteria
Evaluation of the measurements and the segmentations
The mean discrepancy shall be 5mm
Pearson correlation shall be 90
Evaluation of risks
Unanticipated risks should not be critical Evaluation of the security
The detectable error rate shall be 95
The non-detectable error rate shall be 5 Evaluation of PRAEVAorta Web
No critical bug No critical unanticipated risks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None