Post Market Clinical Follow Up Investigation of microSKAN
Not Applicable
Completed
- Conditions
- Respiratory conditions due to unspecified external agent, (2) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified,
- Registration Number
- CTRI/2020/12/029799
- 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.
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.
- Detailed Description
Not available
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 microSKAN 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 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.
Trial Locations
- Locations (1)
JSS Hospital
🇮🇳Mysore, KARNATAKA, India
JSS Hospital🇮🇳Mysore, KARNATAKA, IndiaDr Vikram PatilPrincipal investigator9886896511Vikrampatil@jssuni.edu.in