Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04551183
Status:
WITHDRAWN
Last Update Posted:
2023-06-18
First Post:
2020-09-04
Brief Title:
Comparative Study of a Software With the Gold Standard
Sponsor:
Nurea
Organization:
Nurea
Study Overview
Official Title:
Comparative Study of the PRAEVAorta Device in Patients With an Abdominal Aortic Aneurysm AAA Percentage of Adequacy to the Gold Standard
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study had to be cancelled do to the Covid-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nurea wants to set-up a pivotal phase clinical study for its software PRAEVAorta a decision-making support for diagnosis and follow-up of abdominal aorta aneurysm This study is a comparative study Its purpose is to demonstrate the adequacy of PRAEVAorta to the current Gold Standard in the care of patients with abdominal aortic aneurysm The currently benchmark methods are the maximal diameter method Hand-held measurement of maximum diameter on scan images and the segmentation method for the aneurysm volume manual segmentation of scan images then calculation of the AAA volume by counting the pixels
The hypothesis is that 90 of the segmented patients have a volume ratio and a diameter ration equal to or greater than 90
The hypothesis is that 90 of the segmented patients have a volume ratio and a diameter ration equal to or greater than 90
Detailed Description:
Control and quality assurance will be applied in the investigation site The monitor mandated by the sponsor Nurea will ensure the follow-up and the proper completion of the study the collection of data in writing their documentation recording and report in accordance with the procedures in place and in accordance with good clinical practice as well as the laws and regulations in force
Quality control visits realised at regular intervals will be realised by the monitor During those visits the following elements could be demanded
Informed consent forms information note
Respect of the plan of the study and the procedures defined in it
Quality of the data collected in the Case Report Form CRF accuracy missing data consistency of data with the source documents medical file appointment book originals of laboratory results
Management of any products
Security data All contacts made will give rise to a specific written report
Three type of visits quality control will be realised
The initiation visit realised in person will concern every person potentially involved in the investigation This visit will be about presenting the plan redefine inclusion objectives recall everyones responsibility and the regulation as well as answering question
The monitoring visits will be realised by the monitor after the first inclusion to ensure the respect of the plan and the regulation as well as the quality of the collected data Those visits will be realised every 2weeks but the frequency can vary regarding the complexity of the study of the number and the pace of inclusions Therefore there will be at least one visit per month
The close-out visit will be realised after the last data have been collected The purpose of this visit is to verify the quality of the collected data to update the documents before archiving
In addition to these on-site travels a regular monitoring over the phone will be realised in order to best support the participating physicians throughout the study
These quality controls are supplemented by regular follow-up audits in order to evaluate the quality of collected data and to crop the study An audit may be conducted at any time by persons appointed by the sponsor and independent of the persons conducting the research Its purpose is to verify the participants safety and respect for their rights compliance with applicable regulations and the reliability of data
An inspection can also be carried out by a competent authority ANSM for France or EMA in the context of a European study for example
The audit as well as the inspection can be applied at all stages of the research from the development of the protocol to the publication of the results and the classification of the data used or produced as part of the research
Data management Access to data
Only participating physicians and the monitor or clinical research staff will have access to source files during the monitoring visits
During quality control visits the principal investigator must make the following documents available
informed consent
briefing notes
observation notebooks
source documents medical records appointment books etc In accordance with the law in force patients have a right of access to their medical file According to the law of January 2002 patients will be told where they can inquire about the results of the study
Guidelines for collecting data
The term Case Report Form CRF designates any document whatever its support for example paper optical magnetic or electronic intended to collect in writing all the information required by the protocol concerning each person who is suitable for research and to be sent to the sponsor
All the information required by the protocol must be recorded in case report forms and an explanation must be provided for any missing data The data will have to be collected as and when they are obtained and transcribed in these notebooks in a clear and legible way
It is the responsibility of the investigator to complete the CRF but he may delegate this task to the clinical trial technicians or to the research nurse provided that he has previously completed a task delegation form
Data collection will be done using e-CRF that will include patient characteristics and study data The patient will be identified by an alphanumeric code and the data concerning himher will be anonymized in the form The code will be reported on all pages of the observation book
Modification of e-CRF data
Corrections of errors which have occurred in an e-CRF will be carried out via the correction module thereof and must be dated initialed and justified
The copies of the observation notebooks will be kept for at least 15 years on the investigation site while the original copy once the quality control has been carried out will be archived by the sponsor for the same duration
Standard operating procedures
Investigators will determine whether patients meet the inclusion criteria and whether the use of one or the other device will bring them beneficial results
Screening pre-selection The selection of the patients is realised by the principal investigator A first screening of the patient that could be included in the study is realised
To be pre-included those patients shall
1 be still followed by the hospital for the duration of the study
2 have at least one scheduled visit in the Vascular and General Surgery unit over the study period
3 respect the selection criteria inclusion and exclusion criteria The discrimination of the group of patients is carried out according to the list above
Pre-inclusion visit The presentation of the clinical study and the proposition to participate to it will be presented to the patient by an investigator doctor during one of his follow-up routine visit regarding his care pathway
The investigator surgeon verifies the match to the eligibility criteria The information notes and the consent form are given to the patient at this same visit A reasonable response period is given to the patient to return the consent form signed Its inclusion will be effective upon the return of this signed consent
Reception of the consent form inclusion
When the consent of the patient has been received the following data are registered in the e-CRF
Demographic data Birth date age gender
Investigation data Patient number date of signature of the consent
Images data Pre-operation scan post-operation scan The inclusion is validated when all data cited above are registered in the e-CRF
Sample size assessment
To answer the main objective of this study we set up a precision of the proportion of volumes calculated by the software PRAEVAorta in adequation with the volumes hand calculated by the healthcare professionals
For this statistical analysis variables are quantitative volume of the aneurysm in mm3 We consider over here the proportion of patients images who have a volume ratio less or greater than 90
Volume ratio fracPRAEVAorta volume-hand volumePRAEVAorta volume
Hypothesis are the following
H0 90 of the segmented patients have a volume ratio 90 H1 90 of the segmented patient have a volume ratio 90 We would like to have a precision of this proportion of 10 Therefore the numbers of patients needed with an α risk of 5 and a β risk of 09 is 35
n fracvarepsilon_alpha2bullet pbullet qi2 frac1962times09times01012345 With i precision p proportion q 1 - proportion εα obtained with the reduced table of the normal law
For security reasons and to anticipate the possible withdrawals we choose to include approximately 10 more subjects for a total of 40 patients
Patients will be divided in two groups 20 patients will see their pre-op images analysed and 20 patients will see their post-op images analysed
Satistical analysis plan
To evaluate the segmentation obtained with the software a quantitative comparison with the results obtained from a semi-automatic segmentation manually corrected by a senior and a junior surgeon shall be realised The Dice Similarity Coefficient DSC Jaccard indexJAC Sensitivity Specificity volumetric similarity VS Hausdorff distance HD maximum aortic transverse diameter and the duration of segmentation will be calculated between the two methods and for the semiautomatic software also between the two observers A Pearsons coefficient correlation is done to evaluate the correlation between the volumes surfaces and diameters measures with the fully automatic and manually corrected segmentation methods
Quality control visits realised at regular intervals will be realised by the monitor During those visits the following elements could be demanded
Informed consent forms information note
Respect of the plan of the study and the procedures defined in it
Quality of the data collected in the Case Report Form CRF accuracy missing data consistency of data with the source documents medical file appointment book originals of laboratory results
Management of any products
Security data All contacts made will give rise to a specific written report
Three type of visits quality control will be realised
The initiation visit realised in person will concern every person potentially involved in the investigation This visit will be about presenting the plan redefine inclusion objectives recall everyones responsibility and the regulation as well as answering question
The monitoring visits will be realised by the monitor after the first inclusion to ensure the respect of the plan and the regulation as well as the quality of the collected data Those visits will be realised every 2weeks but the frequency can vary regarding the complexity of the study of the number and the pace of inclusions Therefore there will be at least one visit per month
The close-out visit will be realised after the last data have been collected The purpose of this visit is to verify the quality of the collected data to update the documents before archiving
In addition to these on-site travels a regular monitoring over the phone will be realised in order to best support the participating physicians throughout the study
These quality controls are supplemented by regular follow-up audits in order to evaluate the quality of collected data and to crop the study An audit may be conducted at any time by persons appointed by the sponsor and independent of the persons conducting the research Its purpose is to verify the participants safety and respect for their rights compliance with applicable regulations and the reliability of data
An inspection can also be carried out by a competent authority ANSM for France or EMA in the context of a European study for example
The audit as well as the inspection can be applied at all stages of the research from the development of the protocol to the publication of the results and the classification of the data used or produced as part of the research
Data management Access to data
Only participating physicians and the monitor or clinical research staff will have access to source files during the monitoring visits
During quality control visits the principal investigator must make the following documents available
informed consent
briefing notes
observation notebooks
source documents medical records appointment books etc In accordance with the law in force patients have a right of access to their medical file According to the law of January 2002 patients will be told where they can inquire about the results of the study
Guidelines for collecting data
The term Case Report Form CRF designates any document whatever its support for example paper optical magnetic or electronic intended to collect in writing all the information required by the protocol concerning each person who is suitable for research and to be sent to the sponsor
All the information required by the protocol must be recorded in case report forms and an explanation must be provided for any missing data The data will have to be collected as and when they are obtained and transcribed in these notebooks in a clear and legible way
It is the responsibility of the investigator to complete the CRF but he may delegate this task to the clinical trial technicians or to the research nurse provided that he has previously completed a task delegation form
Data collection will be done using e-CRF that will include patient characteristics and study data The patient will be identified by an alphanumeric code and the data concerning himher will be anonymized in the form The code will be reported on all pages of the observation book
Modification of e-CRF data
Corrections of errors which have occurred in an e-CRF will be carried out via the correction module thereof and must be dated initialed and justified
The copies of the observation notebooks will be kept for at least 15 years on the investigation site while the original copy once the quality control has been carried out will be archived by the sponsor for the same duration
Standard operating procedures
Investigators will determine whether patients meet the inclusion criteria and whether the use of one or the other device will bring them beneficial results
Screening pre-selection The selection of the patients is realised by the principal investigator A first screening of the patient that could be included in the study is realised
To be pre-included those patients shall
1 be still followed by the hospital for the duration of the study
2 have at least one scheduled visit in the Vascular and General Surgery unit over the study period
3 respect the selection criteria inclusion and exclusion criteria The discrimination of the group of patients is carried out according to the list above
Pre-inclusion visit The presentation of the clinical study and the proposition to participate to it will be presented to the patient by an investigator doctor during one of his follow-up routine visit regarding his care pathway
The investigator surgeon verifies the match to the eligibility criteria The information notes and the consent form are given to the patient at this same visit A reasonable response period is given to the patient to return the consent form signed Its inclusion will be effective upon the return of this signed consent
Reception of the consent form inclusion
When the consent of the patient has been received the following data are registered in the e-CRF
Demographic data Birth date age gender
Investigation data Patient number date of signature of the consent
Images data Pre-operation scan post-operation scan The inclusion is validated when all data cited above are registered in the e-CRF
Sample size assessment
To answer the main objective of this study we set up a precision of the proportion of volumes calculated by the software PRAEVAorta in adequation with the volumes hand calculated by the healthcare professionals
For this statistical analysis variables are quantitative volume of the aneurysm in mm3 We consider over here the proportion of patients images who have a volume ratio less or greater than 90
Volume ratio fracPRAEVAorta volume-hand volumePRAEVAorta volume
Hypothesis are the following
H0 90 of the segmented patients have a volume ratio 90 H1 90 of the segmented patient have a volume ratio 90 We would like to have a precision of this proportion of 10 Therefore the numbers of patients needed with an α risk of 5 and a β risk of 09 is 35
n fracvarepsilon_alpha2bullet pbullet qi2 frac1962times09times01012345 With i precision p proportion q 1 - proportion εα obtained with the reduced table of the normal law
For security reasons and to anticipate the possible withdrawals we choose to include approximately 10 more subjects for a total of 40 patients
Patients will be divided in two groups 20 patients will see their pre-op images analysed and 20 patients will see their post-op images analysed
Satistical analysis plan
To evaluate the segmentation obtained with the software a quantitative comparison with the results obtained from a semi-automatic segmentation manually corrected by a senior and a junior surgeon shall be realised The Dice Similarity Coefficient DSC Jaccard indexJAC Sensitivity Specificity volumetric similarity VS Hausdorff distance HD maximum aortic transverse diameter and the duration of segmentation will be calculated between the two methods and for the semiautomatic software also between the two observers A Pearsons coefficient correlation is done to evaluate the correlation between the volumes surfaces and diameters measures with the fully automatic and manually corrected segmentation methods
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