CTRI/2021/03/031852
Completed
Phase 4
A prospective, single arm, post market clinical follow-up of Intra Cath-2 (I.V Cannula) to explore safety and performance in Indian population.
Romsons Scientific and Surgical Industries Pvt Ltd0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Romsons Scientific and Surgical Industries Pvt Ltd
- Enrollment
- 100
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Males and Females above 18 year expected to require intravenous peripheral infusion therapy.
- •2\.Subject who can provide informed consent form in writing and medically in a position to undergo consent and screening process.
- •3\.The subject is willing and able to comply with the requirement of the follow\-up.
Exclusion Criteria
- •1\.Subject who present with medical emergency, where treatment is more priority than the informed consent process.
- •2\.Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc.
- •3\.Allergy with any of the material of Intra Cath\-2 (I.V Cannula) and its component.
- •4\.Subject who is pregnant or breastfeeding.
- •5\.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
- •6\.Participation in another research study involving an active investigation within 30 days prior to consent.
Outcomes
Primary Outcomes
Not specified
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