FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/04/041711 [Registered on: 07/04/2022] Trial Registered Prospectively
Last Modified On: 04/04/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Use of Artificial Intelligence (AI) for identification of Pulmonary Tuberculosis using chest ultrasound videos  
Scientific Title of Study   Exploring the use of Artificial Intelligence (AI) to develop a triaging solution for Tuberculosis using chest ultrasound videos  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alpan Rawal 
Designation  Chief Scientist - AI/ML 
Affiliation  National Entrepreneurship Network (NEN) - Artificial Intelligence Unit 
Address  Wadhwani Institute for Artificial Intelligence Solitaire Corporate Park, Building 11 Floor 7,Chakala, Andheri (E), Mumbai

Mumbai
MAHARASHTRA
400093
India 
Phone  9959099696  
Fax    
Email  alpan@wadhwaniai.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeraj Agrawal 
Designation  Vice President- Health Programs 
Affiliation  National Entrepreneurship Network (NEN) - Artificial Intelligence Unit 
Address  Wadhwani Institute for Artificial Intelligence Solitaire Corporate Park, Building 11 Floor 7,Chakala, Andheri (E), Mumbai

Mumbai
MAHARASHTRA
400093
India 
Phone  9910066734  
Fax    
Email  neeraj@wadhwaniai.org  
 
Details of Contact Person
Public Query  
Name  Dr Neeraj Agrawal 
Designation  Vice President- Health Programs 
Affiliation  National Entrepreneurship Network (NEN) - Artificial Intelligence Unit 
Address  Wadhwani Institute for Artificial Intelligence Solitaire Corporate Park, Building 11 Floor 7,Chakala, Andheri (E), Mumbai

Mumbai
MAHARASHTRA
400093
India 
Phone  9910066734  
Fax    
Email  neeraj@wadhwaniai.org  
 
Source of Monetary or Material Support  
Wadhwani Institute for Artificial Intelligence Foundation, 4, Main Street, Suite 210, Los Altos, CA 94022, USA 
 
Primary Sponsor  
Name  National Entrepreneurship Network NEN Artificial Intelligence Unit 
Address  National Entrepreneurship Network (Artificial Intelligence Unit), 7th Floor, Building No 11, Solitaire Corporate Park, Chakala, Andheri East, Mumbai 400093 Maharashtra, India 
Type of Sponsor  Other [Independent Nonprofit Institute] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukesh P Jagiwala  Anti TB Hospital and Parinbanu Clinic Association  OPD Room No 1, Kamdin Baug, Umiya Chowk, Ashwani Kumar Road, Surat 395008
Surat
GUJARAT 		 9825481018

mukeshjagiwala@yahoo.co.in 
Dr Hasmukhlal Patel  Namrata Heart & Medicare Hospital  Dr Patels Consultation room (next to reception), First Floor, Maruti Complex, Opp. New Civil Hospital, Asarwa, Ahmedabad 380016
Ahmadabad
GUJARAT 		 9824265491

drhjpatel@gmail.com 
Govindlal Narang  Shree Gurunanak Charitable Trust  Chairmans Cabin (Behind OPD Case Paper Section), Gurunanak Hospital, Yogi Krupa Society, Near Shri Gurunanak Devji Marg (Bhatar Road), Surat, Gujarat 395007
Surat
GUJARAT 		 9825885499

sgndh@ymail.com 
Dr Rutul Patel  Trimurti Hospital  Chest Consultation Room, Ground Floor,Trimurti Hospital, NH 08 A, Bavla, Gujarat Ahmadabad
Ahmadabad
GUJARAT 		 8141454801

trimurtihospital@gmail.com 
Dr Sanjay Kumar  Zydus Medical College and Hospital  Chief Executive Officers Cabin, Second Floor, Zydus Hospital, Nimnaliya, Post-Muvaliya, Dahod,Gujarat-389151
Dohad
GUJARAT 		 02673238863

ceo@zmchdahod.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Indian Institute of Public Health Gandhinagar Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. All subjects consenting to be a part of the study. Individual consent (signed and dated informed consent form) 2. 18 years and above of age 3A. For category of TB subjects, include those satisfying the following criteria – (a) Patients should have had any of the following (one or more) symptoms of pulmonary tuberculosis as identified by the clinician at the time of presentation - Persistent cough for 2 weeks or more; Night sweats; Chest pain; Weight loss(unintentional); Shortness of breath; Feeling tired or weak; Fever-Body temperature of more than 100.4 degrees Fahrenheit (CDC) (b)Patients X-Ray chest showing findings suggestive of tuberculosis.(c)Additionally, patients should be Microbiologically confirmed (sputum microscopy/ CBNAAT/ TruNat) OR Clinically diagnosed TB Cases (d) Clinically stable individuals - Individuals that do not require emergency medical attention. 3B. For category of Non-TB subjects, include those satisfying the following criteria – (a) In the Chest symptomatic category: Subjects having symptoms of other chest conditions/pathologies. Chest x-ray findings ruling out pulmonary tuberculosis but may have other findings.(b) In Normal subjects’ category: Subjects should be clinically stable individuals
with no symptoms suggestive of pulmonary conditions. Chest x-ray findings should indicate a clear chest with no lesions 
 
ExclusionCriteria 
Details  1. Consent not given by the individual for enrolment in the study. 2. In the TB positive subjects, exclude all clinically unstable individuals.
3. For Non-TB subjects, in the Normal individual’s category, exclude all clinically ill individuals 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Creating a dataset of Chest X-rays, HRCT and Chest Ultrasound Scans (CUS) of adult subjects.   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. To use this structured dataset to develop an AI-powered screening tool for triaging pulmonary tuberculosis patients from the community
2. To anonymize the dataset by removing all Personal Identifiable Information (PII) and make it publicly available for the global research community.
 		 1 year 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   12/04/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Data access mechanisms to be determined after data collection.

  6. For how long will this data be available start date provided 25-01-2023 and end date provided 30-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The study aims to create a dataset of chest X-rays, HRCT and ultrasound scans of adult subjects as per the enrollment criteria which has 4 categories of patients with specific targets for each category namely 1. Microbiologically positive pulmonary TB patients (X ray & CBNAAT both positive). 2.Clinically positive cases of pulmonary TB (X ray positive but CBNAAT negative) 3. Non TB Patients with some chest pathology (X ray & CBNAAT negative for TB) 4.  Normal Healthy Individuals (X ray & CBNAAT negative for TB and no other pathology). Data will be collected from 5 study sites (Hospitals) across 3 districts in Gujarat namely Ahmedabad, Surat & Dahod. Study Sites have been selected such that they represent the urban, rural & tribal pockets of Gujarat with the highest notifying TB hospitals in these areas. Data of the Chest USG’s will be further annotated by expert radiologist’s to identify features like consolidation, subpleural nodules etc. All this data will be used to develop an AI Algorithm for developing a screening tool that will enable frontline health workers (i.e., TBHV) take a short ultrasound video of the chest of an individual to screen for features of pulmonary tuberculosis, thereby enabling timely triaging for better diagnostics & treatment. The ultimate aim of the study is to develop AI-powered screening/triaging tool for early diagnosis of pulmonary tuberculosis.
 
Close