Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580886
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Validation of Handheld Ultrasound Devices in Rheumatology
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology
Status:
COMPLETED
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:
The goal of this clinical trial is to test the concurrent validity of the Clarius handheld ultrasound devices versus gold-standard device to detect characteristic features of healthy and rheumatic joints in adults Psoriatic Arthtritis patients ie anatomical structures and vascular flow
Detailed Description:
This study is a clinical trial testing the concurrent validity of Clarius handheld ultrasound devices against the gold-standard device to detect characteristics ie anatomical structures and vascular flow of healthy and rheumatic joints in adult Psoriatic Arthritis patients
The study will be conducted in 3 centers and 10 patients will be included in each center Study patients will not be randomized to any group
Both B mode and Doppler images of the participants predetermined nail joint tendon and enthesitis areas will be recorded with both handheld Clarius Mobile Health Inc HD3 L15 scanner HD3 L20 scanner and the gold standard device GE LogicE9E10 at baseline visit
Two paper CRFs patient and physician CRFs will be filled for each patient during the visit and these will be the source document The CRFs eCRFs will be scanned and uploaded to the SharePoint at each center within 3 days after the visit In addition US images of each patient will be uploaded to the SharePoint The paper CRFs source documents will be kept on site US images and CRFs uploaded from each center will be reviewed by the research assistant at Ottawa Hospital Research Institute OHRI center If there are any missing or erroneous data in the CRF copy research assistant will contact the site to ensured that the errors and deficiencies are corrected in source document according to Good Documentation Practice Site should then re-scan the CRF to the SharePoint ensuring sequential versioning Any queries will be confirmed with the site within a week of the data entry Then the analyzed CRFs data will be transferred to Research Electronic Data Capture REDCap version 12418 - 2023 Vanderbilt University by the research assistant at OHRI Before each analysis interim and final all the paper CRFs and REDCap data will be compared for quality assurance
The scoring of the US images will be done blindly by the principal investigator at OHRI as stated below
At the central site OHRI the research assistant will give a unique identifier number to each image for a random quality control and for cross referencing whenever needed The cropped images as detailed below will not have the subject ID visible to the PI at the time of reading but will be accessible for the quality control read-only access The research assistant at OHRI is the only site personnel who has the capacity to uncrop the images in the PowerPoint file password protected files
Images will not contain any identifiable information such as Date of Birth DOB or initials The US images will be transferred to a PowerPoint file by the research assistant at OHRI in JPEG format The research assistant will generate an unblinded master list inaccessible to other site personnel to link the slide numbers with the patients and scanned anatomical sites and the slide will have no other information on the patient number or ID For scoring the images by the PI a random order slide show will be conducted irrespective of the machine used or the anatomical site or patient assessed to ensure blindness to data related to the patient identifiers The PI will not be blinded to the machine that the image was taken with as the JPEG format that is achieved from different machines are identifiable but due to the random order scoring images that belong to the same joint by the different machines are not to be scored consecutively There will be nine separate powerpoint files for images of joints tendons entheses nail including power Doppler and gray scale findings and grey scale file for erosions
If there are missing images for some sites for any of the probes the images that were obtained for the same site using other probes will also be excluded The number of missing jointtendonentheses and nail images will be reported Missing data will not be imputed
After the images are evaluated blindly statistical analysis will be completed as described below
The primary endpoint analysis will be the interrater agreement of detecting any synovitis in B mode with the Clarius and gold standard machine The kappa coefficients will be evaluated using the guideline outlined by Landis and Koch where the strength of the kappa coefficients are 001-020 slight 021-040 fair 041-060 moderate 061-080 substantial 081-100 almost perfect
For secondary outcomes the interrater agreement for the presence of Doppler signals within the joints tenosynovitis erosions nail as well as features of enthesitis hypoechogenicity thickening erosions enthesophytes calcifications will also be evaluated using the same method The agreement of the semiquantitative grading of the intraarticular findings severity synovitis in B mode Doppler signals erosions each being on a scale between 0-3 will be done using weighted kappa analysis
The study will be completed after the imaging of all patients is completed and the analysis of data is done
The study will be conducted in 3 centers and 10 patients will be included in each center Study patients will not be randomized to any group
Both B mode and Doppler images of the participants predetermined nail joint tendon and enthesitis areas will be recorded with both handheld Clarius Mobile Health Inc HD3 L15 scanner HD3 L20 scanner and the gold standard device GE LogicE9E10 at baseline visit
Two paper CRFs patient and physician CRFs will be filled for each patient during the visit and these will be the source document The CRFs eCRFs will be scanned and uploaded to the SharePoint at each center within 3 days after the visit In addition US images of each patient will be uploaded to the SharePoint The paper CRFs source documents will be kept on site US images and CRFs uploaded from each center will be reviewed by the research assistant at Ottawa Hospital Research Institute OHRI center If there are any missing or erroneous data in the CRF copy research assistant will contact the site to ensured that the errors and deficiencies are corrected in source document according to Good Documentation Practice Site should then re-scan the CRF to the SharePoint ensuring sequential versioning Any queries will be confirmed with the site within a week of the data entry Then the analyzed CRFs data will be transferred to Research Electronic Data Capture REDCap version 12418 - 2023 Vanderbilt University by the research assistant at OHRI Before each analysis interim and final all the paper CRFs and REDCap data will be compared for quality assurance
The scoring of the US images will be done blindly by the principal investigator at OHRI as stated below
At the central site OHRI the research assistant will give a unique identifier number to each image for a random quality control and for cross referencing whenever needed The cropped images as detailed below will not have the subject ID visible to the PI at the time of reading but will be accessible for the quality control read-only access The research assistant at OHRI is the only site personnel who has the capacity to uncrop the images in the PowerPoint file password protected files
Images will not contain any identifiable information such as Date of Birth DOB or initials The US images will be transferred to a PowerPoint file by the research assistant at OHRI in JPEG format The research assistant will generate an unblinded master list inaccessible to other site personnel to link the slide numbers with the patients and scanned anatomical sites and the slide will have no other information on the patient number or ID For scoring the images by the PI a random order slide show will be conducted irrespective of the machine used or the anatomical site or patient assessed to ensure blindness to data related to the patient identifiers The PI will not be blinded to the machine that the image was taken with as the JPEG format that is achieved from different machines are identifiable but due to the random order scoring images that belong to the same joint by the different machines are not to be scored consecutively There will be nine separate powerpoint files for images of joints tendons entheses nail including power Doppler and gray scale findings and grey scale file for erosions
If there are missing images for some sites for any of the probes the images that were obtained for the same site using other probes will also be excluded The number of missing jointtendonentheses and nail images will be reported Missing data will not be imputed
After the images are evaluated blindly statistical analysis will be completed as described below
The primary endpoint analysis will be the interrater agreement of detecting any synovitis in B mode with the Clarius and gold standard machine The kappa coefficients will be evaluated using the guideline outlined by Landis and Koch where the strength of the kappa coefficients are 001-020 slight 021-040 fair 041-060 moderate 061-080 substantial 081-100 almost perfect
For secondary outcomes the interrater agreement for the presence of Doppler signals within the joints tenosynovitis erosions nail as well as features of enthesitis hypoechogenicity thickening erosions enthesophytes calcifications will also be evaluated using the same method The agreement of the semiquantitative grading of the intraarticular findings severity synovitis in B mode Doppler signals erosions each being on a scale between 0-3 will be done using weighted kappa analysis
The study will be completed after the imaging of all patients is completed and the analysis of data is done
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