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CTRI Number  CTRI/2025/12/098729 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational Comparative Validation Study 
Study Design  Other 
Public Title of Study   Comparing a wearable patch’s vital sign readings with standard hospital devices in patients. 
Scientific Title of Study   CLINICAL EVALUATION OF A NON INVASIVE WEARABLE DEVICE FOR MULTI PARAMETER HEALTH MONITORING AND PREDICTIVE ANALYSIS 
Trial Acronym  SUSHENA-Vitals Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrJayaraj Mymbilly Balakrishnan 
Designation  MD, Professor  
Affiliation  Kasturba Medical College , MAHE , Manipal 
Address  Professor, Department of Emergency Medicine, Kasturba Medical College and Hospital, Manipal, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9895063580  
Fax    
Email  jayaraj.mb@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  DrJayaraj Mymbilly Balakrishnan 
Designation  MD, Professor  
Affiliation  Kasturba Medical College , MAHE , Manipal 
Address  Professor, Department of Emergency Medicine, Kasturba Medical College and Hospital, Manipal, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9895063580  
Fax    
Email  jayaraj.mb@manipal.edu  
 
Details of Contact Person
Public Query  
Name  DrJayaraj Mymbilly Balakrishnan 
Designation  MD, Professor  
Affiliation  Kasturba Medical College , MAHE , Manipal 
Address  Professor, Department of Emergency Medicine, Kasturba Medical College and Hospital, Manipal, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9895063580  
Fax    
Email  jayaraj.mb@manipal.edu  
 
Source of Monetary or Material Support  
VITRITYA LABS,PRIVATE LIMITED  
 
Primary Sponsor  
Name  Sriram R, Vitritya Private Limited  
Address  No.235, 2nd & 3rd Floor, 13th Cross Road, Indira Nagar II Stage, Hoysala Nagar, Indiranagar(Bangalore), Bangalore North, Karnataka, India,560038 
Type of Sponsor  Other [Private Limited] 
 
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 Jayaraj Mymbilly Balakrishnan  Kasturba Hospital Manipal  Department of Emergency Medicine, Department of General Medicine and Department of Pediatrics Kasturba Hospital Manipal Karnataka India 576104
Udupi
KARNATAKA 		 09895063580

jayaraj.mb@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAHE Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z69-Z76||Persons encountering health services in other circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Day(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Participants will be enrolled across the following age categories
Infants (1 month to 24 months)
Paediatric population (24 months to 17 years)
Adults (18 to 75 years)
All participants must be medically stable, free from any severe chronic illness, and suitable for non-invasive vital sign monitoring. 
 
ExclusionCriteria 
Details  Individuals with implantable medical devices or pregnancy will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Agreement between device and clinical standards  Multiple Time points during the hospital stay  
 
Secondary Outcome  
Outcome  TimePoints 
To assess patient and clinician feedback on comfort, safety, and usability  at the end of data collection process  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   25/12/2025 
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="2"
Months="2"
Days="2" 
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  

This multi-center observational study evaluates an AI-powered wearable device for real-time monitoring of vitals in hospital settings. The study compares device output with hospital monitors, focusing on accuracy, usability, and predictive alerts without altering standard care.

 
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