Post Market Clinical Follow Up Investigation of microSKA
Phase 4
Completed
- Conditions
- Health Condition 1: M859- Disorder of bone density and structure, unspecifiedHealth Condition 2: J709- Respiratory conditions due to unspecified external agent
- Registration Number
- CTRI/2020/12/029799
- Lead Sponsor
- Skanray Technologies Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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. <br/ ><br>Timepoint: 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.Timepoint: Within 14 days after capturing the radiographic images.