Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Exteena UNO (GS-3048 U), Exteena DUO (GS-3048 D),
Exteena TRIO (GS-3048 T),
Exteena QUADRO (GS-3048 Q),
Safsite (GS-3018)
: Device maximum use duration is not more than 5 days
Control I
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and Females Adults & Paediatrics who are expected to require Exteena IV extension line with needle free connector & Safsite IV needle free connector for attachment to IV line 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 who 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
Exclusion criteria: 1 Subject present with medical emergency where treatment is more priority than the informed consent informed assent process 2 Subject having bleeding disorders condition where high pressure power injectors are used etc 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 Exteena IV extension line with needle free connector & Safsite IV needle free connector and its components 5 Other conditions which in the opinion of investigators make the subject unsuitable for enrolment or could interfere with his her participation in and completion of the clinical investigation plan 6 Subject who is pregnant or breast feeding 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary End Point of the study are as 1 Intended for attachment to IV line 2 Facilitating vascular access for the continuous intermittent administration of drugs & solutions through needle free connector 3 IV Extension Line with female luer lock port having a flat swabable surface needle free connector with low prime volume 4 Fitment compatibility with all standard luer devices To use preferably with luer lock syringe 5 Swabable needle free connector surface ensures safe access 6 Improving the quality of life of the subject by achieving the intended clinical purposeTimepoint: Device maximum use duration is not more than 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary End Point of the study are as 1 Device material compatibility with the body tissue and fluids 2 Durability sustainability of device fitment with standard devices over required period of useTimepoint: Device maximum use duration is not more than 5 days | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed