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Clinical Trials/CTRI/2021/04/032495
CTRI/2021/04/032495
Completed
Phase 4

A prospective, single-arm, post-market clinical follow-up of Bi-Valve (Three-way stop cock) to explore safety and performance in Indian population.

Romsons Scientific and Surgical Industries Pvt Ltd0 sites100 target enrollmentTBD
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ConditionsHealth Condition 1: Z69-Z76- Persons encountering health services in other circumstances

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: Z69-Z76- Persons encountering health services in other circumstances
Sponsor
Romsons Scientific and Surgical Industries Pvt Ltd
Enrollment
100
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
February 10, 2024
Last Updated
2 years ago
Study Type
Pms

Investigators

Sponsor
Romsons Scientific and Surgical Industries Pvt Ltd

Eligibility Criteria

Inclusion Criteria

  • •1\.Males and Females above 18 years who are expected to require simultaneous infusions, intermittent drug injections, blood samplings, central venous pressure measurements, arterial add\-on devices used for invasive pressure measurements, blood sampling/s, flushing with normal saline, etc.
  • •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\.Any planned therapy of corrosive medications, photosensitive medication and highly viscous fluids.
  • •3\.Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc.
  • •4\.Any known allergy of material of Three\-way stop cock and its component.
  • •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 protocol.
  • •6\.Subject who is pregnant or breastfeeding.
  • •7\.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
  • •8\.Participation in another research study involving an active investigation within 30 days prior to consent.

Outcomes

Primary Outcomes

Not specified

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