Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: RMS Blood Administration Set SS-3052, Kwic Trans SS-3329, Ventra Fusion SS-3051, Blood Fusion SS-3317, Buretta for Blood SS-3096.: Device maximum use duration is not more than 24 Hours.
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and Females Adults & Paediatrics who are expected to require Blood Administration Set for intermittent or Continuous peripheral intravenous transfusion of blood and blood components. 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 or 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 or LAR Legally Acceptable Representative who is willing and able to comply with the requirement of the follow-up.
Exclusion criteria
Exclusion criteria: 1 Subject who 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 such as unconscious mentally challenged subject OR in case of Paediatrics parent of child or LAR Legally Acceptable Representative who cannot provide Informed Assent Form Child or give permission etc. 3 Any known allergy with any of the material of Blood Administration Set and its components. 4 Other conditions which in the opinion of investigators make the patient unsuitable for enrolment or could interfere with his participation in and completion of the Clinical Investigation Plan or Protocol. 5 Subject who is pregnant or breastfeeding. 6 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 As Intended for continuous blood administration. 2 Facilitating Blood Administration from a container to a Patients peripheral vascular system through a needle or catheter. 3 To provide flow control or regulation while administering blood and blood products. 4 Improving the quality of life of the subject.Timepoint: Use duration of device is not more than 24 Hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary End Point of the study are as 1 Durability sustainability & device fitment of the accessories with standard devices over required period of use. 2 Material Compatibility with the tissue & body Fluids.Timepoint: Use duration of device is not more than 24 Hours. | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed