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Post Market Clinical Follow Up Investigation of Intraskan DC

A prospective, post market, non-interventional observational, open label, single arm, single center study to validate the clinical safety and performance of Intraskan DC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029746
Enrollment
300
Registered
2020-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K038- Other specified diseases of hard tissues of teeth

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Skanray Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Pregnant or suspected to be pregnant based on the opinion of a physician. Infant of age less than 1 year.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Within 14 days after capturing the radiographic images.

Secondary

MeasureTime frame
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 DCTimepoint: Within 14 days after capturing the radiographic images.

Countries

India

Contacts

Public ContactVasundhara R

JSS Dental College and Hospital

drjaishankarhp_dch@jssuni.edu.in9448106487

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026