| CTRI Number |
CTRI/2022/12/047864 [Registered on: 02/12/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Post Market Clinical Follow Up of Skanrays Fixed X-ray Systems (Clinical study to record the safety and performance data of Skanrays Fixed X-ray Systems in real world scenario) |
Scientific Title of Study
Modification(s)
|
Prospective, post market, non - interventional observational, open label, single arm study to confirm the clinical safety and performance of Skanrays Fixed X-ray Systems |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| PLN-000777-0-20 Version 02 07 June 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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 Mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
9886896511 |
| Fax |
|
| Email |
vikrampatil@jssuni.edu.in |
|
Details of Contact Person
Scientific Query
|
| 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 Mysuru
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 Limited |
| Address |
Department of Regulatory Affairs, 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
Modification(s)
|
| Skanray Technologies Limited, Plot 15-17, Hebbal Industrial Area, Mysore 570016 |
|
|
Primary Sponsor
|
| Name |
Skanray Technologies Limited |
| Address |
Plot 15-17, Skanray Technologies Limited, Hebbal Industrial Area, Mysore |
| Type of Sponsor |
Other [[Medical Device Manufacturer]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikram Patil |
JSS Hospital |
Department of Radio-diagnosis and Imaging JSS Hospital Mahathma Gandhi Road Mysuru
Mysore
KARNATAKA |
9886896511
Vikrampatil@jssuni.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee JSS Medical College and Hospital |
Approved |
| Institutional Ethics Committee JSS Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male and female subjects of all age groups.
Subjects undergoing radiographic examination based on the advice of a physician.
Subjects or legally authorized representatives or guardians on behalf of the subject who are able and willing to provide written informed consent to participate in this clinical study.
|
|
| ExclusionCriteria |
| Details |
Subjects who have not been advised for radiographic examination by a physician.
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
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Collection of feedback which includes user’s assessment of the overall safety and performance of the Skanrays Fixed X-ray Systems |
Within 14 days after capturing the radiographic image |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Collection of feedback from the radiographer on the safety, performance & usability of the Skanrays Fixed X-ray Systems.
|
Within 14 days after capturing the radiographic image |
|
Target Sample Size
Modification(s)
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
08/12/2022 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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)
|
Skanrays Fixed X-ray Systems are an advanced high frequency type X-ray system designed for superior image quality with a powerful generator and very low X-ray leakage radiation. The models of Skanrays Fixed X-ray Systems includes SKANRAD 400, SKANRAD 500 and SKANRAD 630.
Intended for use in generating radiographic images of human anatomy in all general - purpose X-ray diagnostic procedures. It may be used in radiology departments, pediatrics, orthopedics and clinics.
The system has been designed for indoor usage. It is intended for qualified medical personnel or operators who have been trained in the use of X-ray equipment. Indicated for chest radiography for detectable infections, orthopaedic fractures and dislocations, digestive disorders studies, arthritis, spinal fractures and pain management.
This device is approved by CDSCO, AERB and BIS.
This clinical study is intended to collect feedback from user in the post market phase.
|