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CTRI Number  CTRI/2023/05/053279 [Registered on: 31/05/2023] Trial Registered Prospectively
Last Modified On: 28/08/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Post-Market Clinical Data Analysis With Skanrays Defibrillators (Clinical study to record the safety and performance data of Skanrays Defibrillators in real world scenario) 
Scientific Title of Study   A prospective, post-market clinical data analysis in patients undergoing cardioversion or defibrillation using Skanrays Defibrillators 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
3-18-010-0139-44 Version 01 28 October 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjappa Mahadevappa 
Designation  Associate Professor 
Affiliation  JSS Hospital 
Address  Department of Cardiology JSS Hospital Mysuru

Mysore
KARNATAKA
570004
India 
Phone  7899584676  
Fax    
Email  manjappam@jssuni.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjappa Mahadevappa 
Designation  Associate Professor 
Affiliation  JSS Hospital 
Address  Department of Cardiology JSS Hospital Mysuru


KARNATAKA
570004
India 
Phone  7899584676  
Fax    
Email  manjappam@jssuni.edu.in  
 
Details of Contact Person
Public Query  
Name  Vasundhara R 
Designation  Head Regulatory Affairs 
Affiliation  Skanray Technologies Limited 
Address  Skanray Technologies Limited Plot 15 16 17 Hebbal Industrial Area Mysore

Mysore
KARNATAKA
570016
India 
Phone  9844761818  
Fax    
Email  vasundhara.r@skanray.com  
 
Source of Monetary or Material Support  
Skanray Technologies Limited Mysuru 
 
Primary Sponsor  
Name  Skanray Technologies Limited 
Address  Plot 15 16 17 Hebbal Industrial Area Mysore 
Type of Sponsor  Other [Medical Device Manufacturer] 
 
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 Manjappa Mahadevappa  JSS Hospital  Department of Cardiology 3rd Floor JSS Hospital Mahatma Gandhi Road Mysuru
Mysore
KARNATAKA 		 7899584676

manjappam@jssuni.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee JSS Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I462||Cardiac arrest due to underlying cardiac condition, (2) ICD-10 Condition: I468||Cardiac arrest due to other underlying condition, (3) ICD-10 Condition: I469||Cardiac arrest, cause unspecified, (4) ICD-10 Condition: I480||Paroxysmal atrial fibrillation, (5) ICD-10 Condition: I481||Persistent atrial fibrillation, (6) ICD-10 Condition: I482||Chronic atrial fibrillation, (7) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, (8) ICD-10 Condition: R001||Bradycardia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cardioversion  Synchronized cardioversion  
Intervention  Defibrillation   External defibrillation 
Intervention  Pacing  Transcutaneous pacing 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Data from the subject that meets the below-mentioned criteria shall be collected.
● Patients with indications for defibrillation/cardioversion/pacing.
● Male and female subjects who weigh above 10 kg. 
 
ExclusionCriteria 
Details  ● Unsafe conditions or surroundings for the use of Direct Current
● Contraindications for defibrillation
A A responsive patient with spontaneous breathing and a palpable pulse.
B Asystole or pulseless electrical activity PEA
● Contraindications for cardioversion - arrhythmias due to enhanced automaticity, such as
digitalis toxicity of digitalis-associated tachycardia, sinus tachycardia, multifocal atrial
tachycardia and junctional tachycardia. Catecholamine-induced arrhythmia having a
homogeneous depolarization state Eg CPVT, shall be excluded.
● Contraindications for pacing - asymptomatic subjects with a reasonably stable rhythm. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To collect clinical data of patients undergoing defibrillation, cardioversion or pacing using
Skanrays Defibrillators. 		 Within 1 day. 
 
Secondary Outcome  
Outcome  TimePoints 
To collect the following data with the use of Skanray defibrillators
a. Clinical feedback from the investigator.
b. Vital physiological parameters (including ECG, NIBP, SPO2) as measured by Skanrays
Defibrillators.
c. Feedback from the user reflecting the ease of defibrillation, cardioversion, pacing and
overall usability.
d. The evidence pertaining to defibrillation, cardioversion, and pacing in the given subject. 		 Within 7 days 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   08/06/2023 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Skanray’s Defibrillators are portable external defibrillator with manual or semi automatic control along with pacing and monitoring of ECG, SpO2 (optional) and NiBP (optional). It employs bi-phasic current or duration controlled shock waveform. The Skanray’s Defibrillators defibrillator / monitor is used for the treatment of life threatening cardiac dysrhythmias by qualified medical personnel familiarised in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation, in a professional healthcare facility under controlled environment. Indicated for manual defibrillation therapy, semi-AED therapy and pacing therapy. This device is approved by European CE and CDSCO (DCGI).
 
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