Post Market Clinical Follow Up Investigation of Intraskan DC

Completed

• Conditions: Other specified diseases of hard tissues of teeth,

• Registration Number: CTRI/2020/12/029746
• Lead Sponsor: Skanray Technologies Pvt Ltd

Brief Summary

This is a post market clinical follow up investigation to validate the safety and performance of Intraskan DC.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

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

Inclusion Criteria

• Male and 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.
• Infant of age less than 1 year.

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 devices Intraskan DC 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 usability. This shall meet the predefined objectives to prove the claimed performance of Intraskan DC	Within 14 days after capturing the radiographic images.

Trial Locations

Locations (1)

JSS Dental College and Hospital; 🇮🇳 Mysore, KARNATAKA, India

JSS Dental College and Hospital

🇮🇳Mysore, KARNATAKA, India

Dr Jaishankar H P

Principal investigator

9448106487

drjaishankarhp_dch@jssuni.edu.in