| CTRI Number |
CTRI/2019/06/019933 [Registered on: 28/06/2019] Trial Registered Prospectively |
| Last Modified On: |
02/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Clinical Validation |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to determine accuracy of test device in low blood oxygen level. |
|
Scientific Title of Study
|
Validation of B.O.L.T Body Life Tracker Device accuracy in measuring Blood Oxygen saturation (SpO2) and Pulse Rate in non-motion controlled desaturation environment in healthy adults as per EVS-EN ISO 80601-2-61:2011. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaurav H Chhaya |
| Designation |
Consultant Physician |
| Affiliation |
Sanjivani Superspeciality Hospital |
| Address |
Department of Medicine, Near, 1, Uday Park Society, Sunrise Park Road, Vastrapur,
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825324056 |
| Fax |
|
| Email |
gaurav.chhaya2010@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya K |
| Designation |
Leader - Qulality |
| Affiliation |
AmZetta Technologies Pvt. Ltd. |
| Address |
Room No: 2,
Quality Department,
Kumaran Nagar, Semmenchery,
Off Rajiv Gandhi Salai (omr)
Chennai
TAMIL NADU
600119
India |
| Phone |
9790917069 |
| Fax |
|
| Email |
divyak@amzetta.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Subham Dutta |
| Designation |
Director |
| Affiliation |
Syncorp Clincare Technologies Pvt. Ltd. |
| Address |
186/2 Tapaswiji Arcade, 2nd floor, BTM Layout 1st Stage, Hosur Main Road
Bangalore
KARNATAKA
560 068
India |
| Phone |
8050072226 |
| Fax |
|
| Email |
subham@syncorp.in |
|
|
Source of Monetary or Material Support
|
| AmZetta Technologies Pvt. Ltd
umaran Nagar, Semmenchery,
Off Rajiv Gandhi Salai (omr)
|
|
|
Primary Sponsor
|
| Name |
AmZetta Technologies Pvt Ltd |
| Address |
Kumaran Nagar, Semmenchery,
Off Rajiv Gandhi Salai (omr) Chennai (TN) 600119
|
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav H Chhaya |
Sanjivani Super speciality hospital |
Near, 1, Uday Park Society, Sunrise Park Road, Vastrapur,
Ahmadabad
GUJARAT |
9825324056
gaurav.chhaya2010@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjivani Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject is willing to give written informed consent for participation in the study.
2. Healthy Male or Female, between 18-45 years of age.
3. Subject willing to undergo controlled desaturation.
4. Subject in a general healthy state with no evidence of ongoing medication and ongoing illness that effect the participation into the study.
5. At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger will be recruited into the study.
|
|
| ExclusionCriteria |
| Details |
1. Subject has any deformity at sensor site location
2. Pregnant women or nursing mothers
3. Subject has known respiratory condition
4. Subject has known cardiovascular disease
5. Subjects with known clotting disorders (self-reported) history of bleeding disorders or personal history of prolonged bleeding from injury, history of blood clots, haemophilia, current use of blood thinner: prescription or daily use of aspirin.
6. Subject on psychotropic drugs
7. Subject with Diabetes
8. Subject with artificial nails or nail polish
9. Subject with Raynaud’s disease
10. Critically ill individuals
11. Smokers
12. Subjects with Haemoglobin <9 g/dL- Self reported
13. Subject with any type of cancer.
14. Subjects with carboxyhemoglobin levels larger than 3%
15. The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
16. Self-reported health conditions as identified in the Health Assessment Form (self-reported), diabetes, thyroid disease, kidney disease / chronic renal impairment, history of seizures (except childhood febrile seizures), epilepsy, history of unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer / chemotherapy.
17. Subject participating in any other clinical trial or have had participated in any clinical trial within last 3 months or is on a follow up for any clinical trial.
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The values obtained from the test device will be compared by the test values obtained by the co-oximeter and statistical analysis will be done as per the EVS-EN ISO 80601-2-61:2011. |
same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of use of test device will be determined as per the list of questionnaires. |
same day |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The SpO2 probe is designed for non-invasive spot-check of arterial oxygen saturation (SpO2) and pulse rate for the intended operator (patient/user) in a home, hospital or clinical environment. The purpose of trial is to determine the accuracy of the test device as per the specified standard.
|