| CTRI Number |
CTRI/2020/12/029836 [Registered on: 16/12/2020] 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 SKAN C |
|
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 SKAN C |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 23-Nov-2020 |
Other |
| PLN-000693-0-20 Version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagaraj Murthy |
| Designation |
Professor and Head of Department |
| 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 |
0821-2335235 |
| Fax |
|
| Email |
nagnishu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagaraj Murthy |
| Designation |
Professor and Head of Department |
| 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 |
0821-2335235 |
| Fax |
|
| Email |
nagnishu@gmail.com |
|
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
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nagaraj Murthy |
JSS Hospital |
Department of
Radio-diagnosis and
Imaging JSS Hospital
Mahathma Gandhi
Road Mysuru
Mysore
KARNATAKA |
0821-2335235
nagnishu@gmail.com |
|
|
Details of Ethics Committee
|
| 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: N359||Urethral stricture, unspecified, (2) ICD-10 Condition: K803||Calculus of bile duct with cholangitis, (3) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (4) ICD-10 Condition: M818||Other osteoporosis without currentpathological fracture, (5) ICD-10 Condition: I830||Varicose veins of lower extremities with ulcer, (6) ICD-10 Condition: T149||Unspecified injury, |
|
|
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 SKAN C 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 features of imaging guidance obtained by the SKAN C during the diagnostic, surgical and interventional procedures and on the usability. This shall meet the predefined objectives to prove the claimed performance of SKAN C. |
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. SKAN C, a mobile surgical C-arm X-ray system, is intended to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. SKAN C is CE certified and available in the market since 2015.
|