Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Yankaur Suction Set
Models
GS-5016A1 to A8.
GS-5016S and GS-5016C.
GS-5014A1 to A8.
GS-5014S and GS-5014C.
Poole Suction GS-5131 & GS-5130.
Suction Connecting Tube GS-5017 & GS-5019 & G
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and Females Adult & Paediatric who are expected to require use of Yankaur Suction Set & Accessories Vaccu Suck Suction Set & Accessories for per-operative suctioning needed for removal of surgical debris secretions blood during surgical procedure. 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 who is present with medical emergency, where treatment is more priority than the informed consent informed assent process. 2 Subject with severe conditions like bleeding disorder coagulopathy 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 the device Yankaur Suction Set & Accessories Vaccu Suck Suction Set & Accessories and or its components. 5 Other conditions which in the opinion of investigators make the patient unsuitable for enrolment or could interfere with his her participation and in completion of the clinical investigation plan 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The Secondary End Point of the study are as 1 Device material compatibility with the body tissues and fluids. 2 Durability sustainability of device during the required period of use.Timepoint: Short Term Use | — |
Primary
| Measure | Time frame |
|---|---|
| The Primary End Point of the study are as 1 Successful per-operative removal of surgical debris-secretions blood by suctioning. 2 Facilitating per-operative removal of surgical debris blood secretions from the operative site successfully by use the device. 3 Improving the visibility & clarity at the surgical site during the surgical operation. 4 Vent port modifiable to provide thumb control during suctioning.Timepoint: Short Term Use | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed