| CTRI Number |
CTRI/2020/12/029799 [Registered on: 15/12/2020] 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 microSKAN |
|
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 microSKAN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 23-Nov-2020 |
Other |
| PLN-000691-0-20 Version 01 |
Protocol Number |
|
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
Mysuru
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
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 Pvt Ltd |
| Address |
Department of Regulatory Affairs, Skanray Technologies Pvt Ltd 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
|
|
|
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 |
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= 1 |
| Name of Committee |
Approval Status |
| 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: J709||Respiratory conditions due to unspecified external agent, (2) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, |
|
|
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 authorized 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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Collection of feedback which includes investigator’s assessment of the overall safety and performance of the microSKAN found to be appropriate to meet the predefined objectives.
|
Within 14 days after capturing the radiographic images. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Collection of feedback from the investigator on the radiographic images collected during the study and on the usability. This shall meet the predefined objectives to prove the claimed performance of microSKAN. |
Within 14 days after capturing the radiographic images. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/12/2020 |
| 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="6"
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
|
Post-market clinical follow-up study is carried out following the CE marking of a medical device and intended to answer specific questions relating to clinical safety or performance of a device when used in accordance with its approved labeling. microSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8 KW generator and very low leakage radiation. microSKAN is CE certified and available in the market from May 2015. |