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Post Market Clinical Follow Up Investigation of SKAN C

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029836
Enrollment
300
Registered
2020-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K803- Calculus of bile duct with cholangitis Health Condition 2: M169- Osteoarthritis of hip, unspecified Health Condition 3: M818- Other osteoporosis without currentpathological fracture Health Condition 4: T149- Unspecified injury Health Condition 5: N359- Urethral stricture, unspecified Health Condition 6: I830- Varicose veins of lower extremities with ulcer

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Skanray Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Pregnant or suspected to be pregnant based on the opinion of a physician.

Design outcomes

Primary

MeasureTime frame
Collection of feedback which includes investigator�s assessment of the overall safety and performance of the SKAN C 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 features of imaging guidance obtained by the SKAN C during the diagnostic, surgical and interventional procedures and on the usability. This shall meet the predefined objectives to prove the claimed performance of SKAN C.Timepoint: Within 14 days after capturing the radiographic images.

Countries

India

Contacts

Public ContactVasundhara R

Department of Radio-diagnosis and Imaging,JSS Hospital

nagnishu@gmail.com0821-2335235

Outcome results

None listed

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