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CTRI Number  CTRI/2020/12/029512 [Registered on: 02/12/2020] Trial Registered Prospectively
Last Modified On: 14/12/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Device study 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker on healthy subjects. 
Scientific Title of Study   Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker to measure SpO2 during hand motion and hand at rest in comparison to “gold‐standard” measurements of blood SaO2 by a CO ‐ OXIMETER, hospital grade pulse oximeter and Over the counter pulse oximeter on healthy subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/CR/CIPL/0408/113 version 01 dated 04 Aug 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Naresh  
Designation  Principal investigator  
Affiliation  ICBio Clinical Research Private limited 
Address  16 and 18 ICBio Tower Yelahanka Main Road Chikkabettahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  91-8023641033  
Fax    
Email  pi.mail@icbiocro.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Harisha S 
Designation  Director Operation  
Affiliation  ICBio Clinical Research Pvt. Ltd. 
Address  16 and 18 ICBio Tower Yelahanka Main Road Chikkabettahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Harisha S 
Designation  Director Operation  
Affiliation  ICBio Clinical Research Pvt. Ltd. 
Address  16 and 18 ICBio Tower Yelahanka Main Road Chikkabettahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
Conzumex Industries Pvt Ltd 
 
Primary Sponsor  
Name  Conzumex Industries Pvt Ltd 
Address  2nd Floor, 1662, 27th Main Rd, Parangi Palaya, Sector 2, HSR Layout, Bengaluru, Karnataka 560102  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
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 Naresh   ICBio Clinical Research Pvt. Ltd.  16 and 18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura
Bangalore
KARNATAKA 		 9900111997

pi.mail@icbiocro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE INDEPENDENT ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Male and female subjects having Age more than 18 -50 years with at least 1/3 darkly skin pigmentation  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  gold‐standard” measurements of blood SaO2 by a CO ‐ OXIMETER  Each subjects one day of device use  
Intervention  Wrist based health tracker device   Calibration on 20 subjects Each day 4 subjects so one week max 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Male and female subjects having Age more than 18 -50 years with at least 1/3 darkly pigmentation
2. Subjects with BMI 18.5-30
3. Subjects wrist size for Female :5.5’to 6.5’ and Male :6.5-7.5’
4. (Carboxyhemoglobin) Co value ≤2.0% FCOHb
5. Hemoglobin value is greater than or equal to 11g/dL
6. Baseline heart rate ≥45bpm and ≤85bpm.
7. Subject is willing to give written informed consent
8. Subject is willing and able to comply with all trial requirements
9. A negative pregnancy test result in women of childbearing potential.
 
 
ExclusionCriteria 
Details  1.The subject is obese (BMI is greater than 30).
2.The subject has a known history of heart disease, lung disease, kidney or liver disease.
3.Diagnosis of asthma, sleep apnea, or use of CPAP.
4.Subject has diabetes.
5.Subject has a clotting disorder.
6.The subject a hemoglobinopathy or history of anemia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
●Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker to measure SpO2 ranges (100-97, 97-92, 92-85, 84-78) during hand motion in in comparison to
I.Gold‐standard” measurements of blood SaO2 by a CO ‐ OXIMETER
II.In comparison to hospital grade pulse oximeter
III. In comparison to Over the counter pulse oximeter
 		 SpO2 ranges (100-97, 97-92, 92-85, 84-78)- one time use  
 
Secondary Outcome  
Outcome  TimePoints 
1. Means for delivering medical-grade oxyg/en-nitrogen mixtures of varying fractional inspired oxygen (FiO2) levels.
2. To evaluate safety and performance of device
 		 SpO2 ranges (100-97, 97-92, 92-85, 84-78) one time use  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/12/2020 
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="0"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker to measure SpO2 during hand motion and hand at rest  in comparison to “gold‐standard” measurements of blood SaO2 by a CO ‐ OXIMETER, hospital grade pulse oximeter and Over the counter pulse oximeter on healthy subjects.

Total of 40 subjects

The study will be performed on 30 subjects, the data collected from the 20 subjects will be used to calibrate and improve the algorithm accuracy of the wrist based tracker. Data collected from next 10 subjects will be used by sponsor for internal validation. 10 Days gap will be there to develop the   algorithm and improve the final validation study.

10 new subjects will be enrolled for evaluating and documenting the accuracy of MUSE tracker and validation report will be prepared.
                                                                                                                        
 
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