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Clinical Trials/CTRI/2024/02/063337
CTRI/2024/02/063337
Recruiting
Phase 4

A prospective, single arm, post market clinical follow-up of Infant Feeding Tube (Feedy) to explore safety and performance in paediatric subjects in Indian population. - NI

Romsons Group Private Limited0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: O- Medical and Surgical

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: O- Medical and Surgical
Sponsor
Romsons Group Private Limited
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Pms

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1 Paediatrics male and female who are expected to require enteral nutrition feeding introduction of fluids etc. in paediatrics whose parents legal guardians are willing to provide written informed assent form will be eligible for inclusion in the follow\-up.
  • •2 Subjects parent LAR Legally Acceptable Representative can provide Informed Assent Form Child.
  • •3 Parents or legal guardians must be able to complete all relevant follow\-up procedures during follow\-up participation.

Exclusion Criteria

  • •1 Subject who present with medical emergency where treatment is more priority than the informed assent process.
  • •2 Subjects paediatrics with severe malabsorption intestinal obstruction.
  • •3 History of any reaction or hypersensitivity likely to be exacerbated by any components of the Infant Feeding Tube or Feedy.
  • •4 Subject with congenital defect or serious chronic illness.
  • •5 Other conditions which in the opinion of investigators make the subject unsuitable for enrolment or could interfere with his participation in and completion of the clinical investigation plan.
  • •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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