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CTRI Number  CTRI/2020/09/028059 [Registered on: 25/09/2020] Trial Registered Prospectively
Last Modified On: 14/05/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Post Market Clinical Follow Up Investigation of Skanmobile and Skanmobile DR 
Scientific Title of Study   A prospective, post market, non-interventional observational, open label, single arm, single center study to validate the clinical safety and performance of Skanmobile and Skanmobile DR 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SKAN/RAD/2020/01  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Vikram Patil 
Designation  Associate Professor 
Affiliation  Department of Radio-diagnosis and Imaging JSS Hospital 
Address  Department of Radio-diagnosis and Imaging JSS Hospital Mahathma Gandhi Road Mysore

Mysore
KARNATAKA
570004
India 
Phone  9886896511  
Fax    
Email  Vikrampatil@jssuni.edu.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Vikram Patil 
Designation  Associate Professor 
Affiliation  Department of Radio-diagnosis and Imaging JSS Hospital 
Address  Department of Radio-diagnosis and Imaging JSS Hospital Mahathma Gandhi Road Mysore

Mysore
KARNATAKA
570004
India 
Phone  9886896511  
Fax    
Email  Vikrampatil@jssuni.edu.in  
 
Details of Contact Person
Public Query  
Name  Vasundhara R 
Designation  Head- Regulatory Affairs 
Affiliation  Skanray Technologies Pvt Ltd 
Address  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 Pvt Ltd, Plot 15 16 17, Hebbal Industrial Area, Mysore - 570016 
 
Primary Sponsor  
Name  Skanray Technologies Pvt Ltd 
Address  Plot 15 16 17, Hebbal Industrial Area, Mysore - 570016 
Type of Sponsor  Other [Medical Device Manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikram Patil  Department of Radio-diagnosis and Imaging JSS Hospital  Department of Radio-diagnosis and Imaging, JSS Hospital, Mahathma Gandhi Road Mysore
Mysore
KARNATAKA 		 9886896511

Vikrampatil@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: J709||Respiratory conditions due to unspecified external agent, (2) ICD-10 Condition: M259||Joint disorder, unspecified, (3) ICD-10 Condition: N219||Calculus of lower urinary tract, unspecified, (4) ICD-10 Condition: M955||Acquired deformity of pelvis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Male and non pregnant female subjects of all age groups.
Subjects or legally authorised representatives or guardians on behalf of the subject who are able and willing to provide written informed consent to participate in this clinical investigation.
 
 
ExclusionCriteria 
Details  Pregnant or suspected to be pregnant based on the opinion of a physician. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Collection of feedback which includes investigator’s assessment of the overall safety and performance of the Skanmobile and Skanmobile DR found to be appropriate to meet the predefined objectives.  Within 14 days after capturing the radiographic image 
 
Secondary Outcome  
Outcome  TimePoints 
Collection of feedback from the investigator on the radiographic images collected during the study and usability. This shall meet the predefined objectives to prove the claimed performance of Skanmobile and Skanmobile DR.  Within 20 days after capturing the radiographic image. 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   28/09/2020 
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="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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)  
Post-market clinical follow-up study is carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance of a device when used in accordance with its approved labeling.

Skanmobile is an advanced high frequency mobile diagnostic X-ray system intended for the use in generating radiographic images of human anatomy for general purpose X-ray diagnostic procedures. Skanmobile DR is a variant of Skanmobile with additional feature of flat panel detector, toughbook and imaging software to acquire the image. 

Skanmobile and Skanmobile DR are CE certified and available in the market since from 2014 and 2019 respectively. 

This is the post market clinical follow up study to proactively collect and review experience gained from the devices placed on the market to ensure the safety and performance of the Skanmobile and Skanmobile DR.
 
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