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CTRI Number  CTRI/2025/04/083926 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 31/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Using Artificial Intelligence to Analyze CT Scans For Lung Emphysema 
Scientific Title of Study   Application/API Based Artificial Intelligence Enhanced Analysis Of Pulmonary Emphysema Using Computed Tomography Imaging Of Thorax 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Michael Antony Vikram 
Designation  Post Graduate 
Affiliation  Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences 
Address  Room no.50, Department of Radiology, Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences,Saveetha Nagar,Thandalam, Chennai, India

Chennai
TAMIL NADU
602105
India 
Phone  8610774083  
Fax    
Email  mikevikram97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Muthiah Pitchandi 
Designation  Professor 
Affiliation  Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences 
Address  Room no.50, Department of Radiology, Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences,Saveetha Nagar,Thandalam, Chennai, India

Chennai
TAMIL NADU
602105
India 
Phone  9843175404  
Fax    
Email  drmuthiahmd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Michael Antony Vikram 
Designation  Post Graduate 
Affiliation  Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences 
Address  Room no.50, Department of Radiology, Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences,Saveetha Nagar,Thandalam, Chennai, India


TAMIL NADU
602105
India 
Phone  8610774083  
Fax    
Email  mikevikram97@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 
 
Primary Sponsor  
Name  Dr. Michael Antony Vikram 
Address  Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105  
Type of Sponsor  Other [[SELF]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Michael Antony Vikram  Saveetha Medical College And Hospital  Room no 50, Department of Radiology, Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai.
Chennai
TAMIL NADU 
8610774083

mikevikram97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J439||Emphysema, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Population Criteria: Individuals at varying stages of emphysema risk, including patients with existing CT scans and relevant data.
2.Medical History: Patients with complaints of new onset of breathlessness/documented respiratory conditions (including emphysema and related lung diseases)
3.CT Scan Data: High-quality CT scans showing clear lung structures.
4.Patients of both gender.
5.Patients who have provided informed consent to participate in the study. 
 
ExclusionCriteria 
Details  1.Patients who are pregnant.
2.Individuals with other chronic diseases, such as cancer, auto-immune disorders which might affect the study results, will not be included.
3.Patients with surgical history (especially involving the thorax)
4.Individuals with CT Scans of poor quality or artifacts that may compromise accurate assessment of lung parenchyma.
5.Patients who are unable to provide informed consent or participate in the study due to cognitive impairment, language barriers, or other reasons.
6.Patients who are not willing to be part of the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To detect the presence of emphysema using AI-driven analysis of CT scans of thorax  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the accuracy and clinical utility of the AI model.  1 week. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/04/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

The invention provides a novel, AI-powered solution for the automated detection and quantification of emphysema using CT thorax imaging. Emphysema, a major component of Chronic Obstructive Pulmonary Disease (COPD), is traditionally assessed through manual interpretation of CT scans, which is time-consuming, subjective, and prone to interobserver variability. This invention addresses these limitations by introducing an application/API module that integrates advanced AI algorithms with existing medical imaging systems.

The core of the invention is an AI-based mobile application and API interface designed to process CT thorax images, enabling precise analysis of lung parenchyma. The AI algorithms are trained on extensive datasets to detect subtle patterns of emphysema, classify subtypes, and provide quantitative metrics of disease severity and progression. Results are delivered in real time, ensuring prompt feedback for clinical decision-making.

The system is equipped with a user-friendly mobile interface that facilitates seamless uploading of CT images, real-time processing via cloud-based infrastructure, and intuitive presentation of results. It is scalable, adaptable to diverse healthcare settings, and supports integration with existing imaging workflows, enabling widespread adoption. Additionally, the invention provides opportunities for use in telemedicine, remote consultations, and longitudinal disease monitoring.

This invention offers a transformative approach to emphysema assessment, improving diagnostic accuracy, reproducibility, and efficiency. It aligns with the evolving needs of precision medicine in respiratory care and contributes to advancements in clinical practice, research, and patient outcomes. 
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