CTRI/2020/12/029799CompletedUnknown
A prospective, post market, non-interventional observational, open label, single arm, single center study to validate the clinical safety and performance of microSKAN
Skanray Technologies Pvt Ltd1 site in 1 country300 target enrollmentStarted: December 16, 2020Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 1.00 Day(s) to 99.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
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.
Time Frame: Within 14 days after capturing the radiographic images.
Secondary Outcomes
- 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.)
Investigators
Study Sites (1)
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