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Clinical Trials/CTRI/2022/10/046321
CTRI/2022/10/046321CompletedPhase 4

A prospective, single arm, post market clinical follow-up of Infusion Set to explore its safety and performance in Adult & Paediatric subjects in Indian Population.

Romsons Group Private Limited0 sites100 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
100
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Pms

Eligibility Criteria

Inclusion Criteria

  • •1.Males and Females (Adult & Paediatric) who are expected to require Infusion Set.
  • •2.Subject who can provide Informed Consent Form (Adult) in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) can provide Informed Assent Form (Child).
  • •3.The subject is willing and able to comply with the requirement of the follow-up. OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) who 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/informed assent process.
  • •2.Subject with bleeding disorder, extensive malignant skin involvement, multicoated effusions, located fluid accumulations, hepatic hydrithorax.
  • •3.Subject, who cannot provide Informed Consent Form (Adult) such as unconscious, mentally challenged subject, OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) who cannot provide Informed Assent Form (Child) or give permission etc.
  • •4.Any known allergy with any of the material of Infusion Set and its component(s).
  • •5.Subject who is pregnant or breast feeding.
  • •6.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
  • •7.Participation in another research study involving an active investigation within 30 days prior to consent.

Investigators

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