Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Vein-O-Line (GS-3034)
Vein-O-Line ‘L’ (GS-3032)
Vein-O-Line ‘T’ (GS-3034 T)
Vein-O-Line ‘Marvel’ (GS-3144)
Vein-O-Line ‘Marvel Plus’ (GS-3153)
Rota Flo (SS-3303): Device maximum use d
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and Females (Adult & Paediatric) who are expected to require Extension Line for administration of intravenous infusions. 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, who cannot provide Informed Consent Form (Adult) in general such as unconscious, mentally challenged subject, vulnerable subject, or in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) who cannot provide Informed Assent Form (Child) or give permission etc. 3. Any known allergy of material of Extension Line and its component(s). 4. Any other contra-indication pertaining to the use of Extension Line. 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Administration of intravenous fluids as intended. 2. Duration of use. Timepoint: Device maximum use duration is 5 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Material Compatibility with the IV Fluids / medicines. 2. Secure Fitment with connection / combination devices. 3. Routine disinfection of the swabable needle free port 4. Kink Resistant Tubing. 5. Consistent flow of medications.Timepoint: Device maximum use duration is 5 days. | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed