Post Market Clinical Follow Up Investigation of SKAN C

Not Applicable

Completed

• Conditions: 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,

• Registration Number: CTRI/2020/12/029836
• Lead Sponsor: Skanray Technologies Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-16
• Last Update Posted: 2022-05-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

Pregnant or suspected to be pregnant based on the opinion of a physician.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

JSS Hospital; 🇮🇳 Mysore, KARNATAKA, India

JSS Hospital

🇮🇳Mysore, KARNATAKA, India

Dr Nagaraj Murthy

Principal investigator

nagnishu@gmail.com