Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401889439833 Date of Registration: 12/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessing safety and clinical performance of Nanox.ARC device
Official scientific title Multicentric study for assessing safety and clinical performance and safety of Nanox.ARC in providing additional information to conventional two-dimensional (2D) radiography when evaluating adult individuals with known or suspected radiographic abnormalities
Brief summary describing the background and objectives of the trial Imaging plays a crucial role in the diagnosis and management of all kinds of diseases and medical conditions. Several imaging modalities such as conventional radiography, advanced imaging modalities like CT, and MRI are available today for the diagnosis of medical conditions and indications.Tomosynthesis is a new method for diagnosis performing high-resolution limited-angle tomography at radiation dose levels comparable with 2D radiography.This imaging modality combines digital image acquisition and processing with simple source/detector motion as used in conventional CT.Notwithstanding the similarities to CT,it is a different technique.This study is to evaluate the diagnostic potential of DTS of a new imaging system called Nanox.ARC in cases of musculoskeletal,pulmonary,or abdominal suspected lesions.The study procedures are carried out with the Nanox.ARC DTS in addition to the standard of care of imaging modalities,and its purpose is to examine whether the images obtained by the new system allow for a good medical diagnosis and can save in the future the need for advanced imaging such as CT and/or MRI and to assess if the system has the potential to reduce reliance on advanced imaging modalities,thereby minimizing radiation exposure associated with the latter.The study objectives are the following:1st Objective:Assess the safety and clinical performance of Nanox.ARC DTS in providing additional information to conventional 2D radiography when evaluating adult individuals with known or suspected radiographic abnormalities.2nd Objectives:1.Evaluate the ability of Nanox.ARC DTS to reduce the need for a CT/MRI or other advanced imaging modality.2.Evaluate the ability of Nanox.ARC DTS to increase the level of confidence of the reader in identifying/excluding an abnormality.3.Evaluate the physician’s reading time of Nanox.ARC DTS compared to CT/MRI or other advanced imaging modality.4.Evaluate the length and extent of the learning curve of reading the tomosynthesis images
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) NAN03
Disease(s) or condition(s) being studied Cancer,Musculoskeletal Diseases,Orthopaedics,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 02/02/2024
Actual trial start date
Anticipated date of last follow up 03/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nanox.ARC Single visit with Nanox.ARC Imaging acquisition with Nanox.ARC 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Age: 18 years old or older (there is no upper limit in age) 2.Maximal weight: 150 kg 3.Suspected or confirmed musculoskeletal, pulmonary, or abdominal lesion (such as fractures, erosions, lung diseases, and renal calculi) 4.An available recent conventional 2D radiograph of the body part where the suspected abnormality(ies) is (are). The conventional 2D radiograph diagnosis must available on the date of enrollment. The following time frame between the radiograph and the Nanox.ARC DTS should be as follows: fracture: 2 weeks, lung infiltration, renal calculi, pleural effusion, and pneumothorax: 1 week, and bone erosions: 1 month. 5.An available or scheduled advanced imaging study (CT scan or MRI) of the same body part. The advanced imaging diagnosis may have been already performed before the study enrollment day, however the same time frame mentioned above between the Nanox.ARC DTS and the CT or MRI should be followed. 6.Being cooperative during the Nanox.ARC DTS imaging exam procedure. 7.The candidate has received all the study details and signed an informed consent form. 1.Known or suspected pregnancy. 2.Inability to cooperate during the study and/or to maintain the required position during Nanox.ARC procedures. Nanox.ARC 3.Underwent a change in the medical condition in the same body part since the 2D radiogra 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 04/12/2023 University of Ghana Medical Centre Institutional Review Board UGMC IRB
Ethics Committee Address
Street address City Postal code Country
Indian Ocean Link, University of Ghana, Legon Campus Accra 0000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rate of cases in which Nanox.ARC DTS provided additional information to conventional 2D radiography when evaluating adult individuals with known or suspected radiographic abnormalities. Interim and final analysis
Secondary Outcome Rate of cases in which the Nanox.ARC information was sufficient for subject management without the need for CT/MRI or other advanced imaging studies modalities Interim and final analysis
Secondary Outcome Rate of cases in which the DTS increased the level of confidence of the reader in identifying/excluding an abnormality Interim and final analysis
Secondary Outcome Duration of physician reading time of Nanox.ARC DTS versus CT/MRI or other advanced imaging modality Interim and final analysis
Secondary Outcome Consensus in the majority of the evaluation points between the site readers and IRC members Interim and final analysis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UGMC University of Ghana Medical Centre, Indian Ocean Link, Legon Campus ACCRA Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
NANOX 94 shlomo Shmeltzer rd. Petach Tikva 4910402 Israel
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NANOX 94 shlomo Shmeltzer rd. Petach Tikva 4910402 Israel Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
MedClinical 85 rue Blomet Paris 75015 France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator George Boateng KYEI gkyei@noguchi.ug.edu.gh 00233551989937 University of Ghana Medical Centre, Indian Ocean Link, Legon Campus
City Postal code Country Position/Affiliation
ACCRA Ghana Research Assistant Professor of Medicine and Molecular Microbiology
Role Name Email Phone Street address
Public Enquiries Yael Schiffenbauer yael.s@nanox.vision 00972544315315 94 shlomo Shmeltzer rd.
City Postal code Country Position/Affiliation
Petach Tikva 4910402 Israel Head of Clinical
Role Name Email Phone Street address
Scientific Enquiries Nogah Shabshin nogah.s@nanox.vision 00972522220027 94 shlomo Shmeltzer rd.
City Postal code Country Position/Affiliation
Petach Tikva 4910402 Israel Head of Tomosynthesis
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes It is planned to share study results with IPD which will be coded. No direct personal identifiers are included in the coded data. Coded data will be used as planned in this study as well as within related research activities in order to: - Understand how Nanox.ARC and similar devices work in the body; - Learn from past studies to plan new studies or improve scientific analysis methods; - Publish research results in scientific journals. The study not started yet. As soon we progress with the first site recruitment, it will be updated Informed Consent Form Data requests can be submitted after article publication. Data obtained from this study may be provided to qualified researchers with an interest in imaging modalities. Any data or images shared will be coded, with no protected Health Information (PHI) included. The subject included in the study must give their consent for data sharing by signing the information and consent form related to the study; prerequisites for data sharing. For more information or to submit a request, please contact Yael Schiffenbauer: yael.s@nanox.vision
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information