Post Market Clinical Follow Up Investigation of Skanmobile and Skanmobile DR

Not Applicable

Completed

• Conditions: 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,

• Registration Number: CTRI/2020/09/028059
• Lead Sponsor: Skanray Technologies Pvt Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-28
• Last Update Posted: 2022-05-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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.

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 Skanmobile and Skanmobile DR found to be appropriate to meet the predefined objectives.	Within 14 days after capturing the radiographic image

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Radio-diagnosis and Imaging JSS Hospital; 🇮🇳 Mysore, KARNATAKA, India

Department of Radio-diagnosis and Imaging JSS Hospital

🇮🇳Mysore, KARNATAKA, India

Dr Vikram Patil

Principal investigator

9886896511

Vikrampatil@jssuni.edu.in