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Post Market Clinical Follow Up of Skanrays Fixed X-ray Systems (Clinical study to record the safety and performance data of Skanrays Fixed X-ray Systems in real world scenario)

Prospective, post market, non - interventional observational, open label, single arm study to confirm the clinical safety and performance of Skanrays Fixed X-ray Systems

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/047864
Enrollment
250
Registered
2022-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: B- Imaging

Interventions

Intervention1: NA: NA Control Intervention1: NA: NA

Sponsors

Skanray Technologies Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male and female subjects of all age groups. Subjects undergoing radiographic examination based on the advice of a physician. 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 study.

Exclusion criteria

Exclusion criteria: Subjects who have not been advised for radiographic examination by a physician. Pregnant or suspected to be pregnant based on the opinion of a physician.

Design outcomes

Primary

MeasureTime frame
Collection of feedback which includes user’s assessment of the overall safety and performance of the Skanrays Fixed X-ray SystemsTimepoint: Within 14 days after capturing the radiographic image

Secondary

MeasureTime frame
Collection of feedback from the radiographer on the safety, performance & usability of the Skanrays Fixed X-ray Systems. Timepoint: Within 14 days after capturing the radiographic image

Countries

India

Contacts

Public ContactVasundhara R

Department of Radio-diagnosis and Imaging JSS Hospital

vikrampatil@jssuni.edu.in9886896511

Outcome results

None listed

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