| CTRI Number |
CTRI/2024/06/068307 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Validation of the AI-enabled software tool for utilizing a traditional chest X-ray to screen for osteoporosis and related fracture risk |
|
Scientific Title of Study
|
A clinical validation study to test and compare the accuracy of iOsteoporos Screen (an intelligent Osteoporosis Screening Solutions Tool), a fully automated AI enabled digital health tech solutions system for screening Osteoporosis & Osteopenia and its associated high future risk for fracture at hip and spine using a conventional chest X-ray, acquired during a general health checkup in post-menopausal women and geriatric patients with BMD DXA Scans of bilateral hips and spine and the calculated future risks for fractures using the online FRAX Tool for the Indian population as the standards respectively |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshini Maria Abraham |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Chettinad Hospital and Research Institute, Block-D, Dept. of Radiology, Chettinad Academy of Research and Education (CARE), Rajiv Gandhi Salai, Kelambakkam, Chennai, Tamil Nadu, India.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9789662359 |
| Fax |
|
| Email |
roshini.m.koshy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrs V S Felix Enigo |
| Designation |
Founder and CEO |
| Affiliation |
Diagno Intelligent Systems Private Limited |
| Address |
Diagno Intelligent Systems Private Limited
Plot No 92, VGP Vimala Nagar, Medavakkam,
Chennai, Tamil Nadu, India
Kancheepuram
TAMIL NADU
600100
India |
| Phone |
9444662464 |
| Fax |
|
| Email |
felix.enigo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrs V S Felix Enigo |
| Designation |
Founder and CEO |
| Affiliation |
Diagno Intelligent Systems Private Limited |
| Address |
Diagno Intelligent Systems Private Limited
Plot No 92, VGP Vimala Nagar, Medavakkam,
Chennai, Tamil Nadu, India
Kancheepuram
TAMIL NADU
600100
India |
| Phone |
9444662464 |
| Fax |
|
| Email |
felix.enigo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Diagno Intelligent Systems Private Limited
Plot No 92, VGP Vimala Nagar, Medavakkam,
Chennai, Tamil Nadu, India. Pincode-600100 |
|
|
Primary Sponsor
|
| Name |
Diagno Intelligent Systems Private Limited |
| Address |
Diagno Intelligent Systems Private Limited
Plot No 92, VGP Vimala Nagar, Medavakkam,
Chennai, Tamil Nadu, India. Pincode-600100 |
| Type of Sponsor |
Other [Startup] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roshini Maria Abraham |
Chettinad Hospital & Research Institute |
Chettinad Hospital & Research Institute, A-Block, Division 8, Dept. of Orthopaedics, Room No 8, Chettinad Hospital & Research Institute, Chettinad Academy of Research & Education (CARE), Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai-603103, Kanchipuram District, Tamil Nadu, India.
Kancheepuram
TAMIL NADU |
9789662359
roshini.m.koshy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Academy of Research and Education Institutional Human Ethics Committee for Faculty Research- CARE IHEC-II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL as it is an observational study |
NIL as it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
i).Post-menopausal Women
ii).Geriatric patients, both female and male, aged 45 years and above
iii).Known cases of osteoporosis, with and without a previous fracture |
|
| ExclusionCriteria |
| Details |
i).Patient, who will be suffering from the following chronic diseases will be excluded: Thyroid disease (Hypothyroidism and Hyperthyroidism), Cancer, Chronic Liver Diseases, Chronic Kidney Diseases, Chronic Heart Diseases, Organ Transplantation (Kidney, Liver, etc), Severe accident-induced fractures
ii).Patient with the following: pacemaker, defibrillator, internal fixations for vertebra and clavicle fracture, bone cement, other foreign metal object
iii).Patient with abnormal chest imaging, pneumonia, abnormal lung lesions
iv).Patient with artifact in chest image, low-quality image
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i).The accuracy of iOsteoporos Screen (an intelligent Osteoporosis Screening Software Tool) will be evaluated , when compared to BMD by DXA and the computed FRAS Score as the Standards. Its accuracy would be more than 95%
ii).iOsteoporos Screen Tool can be used as an opportunistic screening tool for Osteoporosis & its risk for fracture using a chest X-ray. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| i). Total umber of patients, aged above 45 years who are in the risk for osteoporosis & its future high risk for fracture will be predicted. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Patents Published:
1). India: System and Method for Bone Fracture Risk Assessment
Patent No: 202241067402, 2024
2). PCT: System and Method for Bone Fracture Risk Assessment
Patent No: WO2024110991, 2024 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
1) 1. “iOsteoporos Screen†is a novel Artificial Intelligence (AI) enabled Screening Software Tool that assess the conventional chest X-ray (in DICOM/ JEPG format) of a patient and gives an automated computerised test report whether the patient is osteoporotic or normal. 2. It is a retrospective type of Observational Study that uses the already taken chest X-ray for screening Osteoporosis. Also, it is non-invasive and there is no intervention involved in this study. 3. We have obtained Institutional Ethical Committee Approval for this study. 4. This study uses OLD DATA from
the medical records.
|