| CTRI Number |
CTRI/2024/10/075254 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Validation Study of AI-enabled Screening Software Solutions Tool to predict Osteoporosis and related Fracture Risk using a conventional chest X-ray |
|
Scientific Title of Study
|
A cross-sectional clinical validation study to test and compare the accuracy of iOsteoporos Screen (an intelligent Osteoporosis Screening Solutions System), a fully automated AI enabled digital health tech solutions tool 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 |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpa Avarebeel |
| Designation |
Associate Professor |
| Affiliation |
JSS Medical College & Hospital |
| Address |
Department of Geriatrics,
JSS Medical College & Hospital,
M.G.Road, Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9880053998 |
| Fax |
|
| Email |
shilpaavarebeel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrs V S Felix Enigo |
| Designation |
Founder & CEO |
| Affiliation |
Diagno Intelligent Systems Private Limited |
| Address |
Diagno Intelligent Systems Private Limited
Plot No 92, VGP Vimala
Nagar, Medavakkam, Chennai, Tamil Nadu
Kancheepuram
TAMIL NADU
600100
India |
| Phone |
9444662464 |
| Fax |
|
| Email |
felix.enigo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rovin M Theempalangad |
| Designation |
Clinical Research Associate |
| Affiliation |
JSS Medical College & Hospital |
| Address |
JSS Medical College & Hospital,
JSS Academy of Higher Education & Research, M.G.Road, Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
7034899141 |
| Fax |
|
| Email |
rovinmathewt@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 Shilpa Avarebeel |
JSS Hospital |
Room number-1001, Department of Geriatrics, First Floor, Main Building, JSS Hospital, MG Road, Mysore-570004
Karnataka
Mysore
KARNATAKA |
9880053998
shilpaavarebeel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Medical College, Institutional Ethical Committee |
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 |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
i).Post-menopausal Women
ii).Geriatric patients of both female
and male
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 X-ray, 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 Solutions
Tool) will be evaluated, when compared to BMD by DXA Scans and the computed FRAX Score for the Indian populations 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 at hip and spine using a chest X-ray. |
3-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total number of patients, aged above 45 years
who are in the risk for osteoporosis & its future
high risk for fracture at hip and spine will be predicted. |
3 - 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. “iOsteoporos Screen†is a newly developed novel Artificial Intelligence (AI) enabled Screening Software Solutions Tool that assess the conventional chest X-ray Image (in DICOM/ JEPG format) of a patient and gives a prediction of whether the patient is osteoporotic or normal. Also, it predicts high risk for future fracture with high accuracy. It gives an automated computerized patient’s test report and it can be used as a Clinical Decision Support System to doctors. 2. It is an Observational Study to validate the AI-enhanced Software Tool referred above. Also, it is a non-invasive study and there is no intervention involved in this study. 3. We have obtained Institutional Ethical Committee Approval for this study. |