Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Romolene GS-4032, Ryles Tube GS-4004, Levin’s Tube GS-4006 Sizes FG 6,8,10,12,14,16,18,20 & Salem Tube GS-4018 sizes FG 10,12,14,16,18,20 & Gastrolene PUR GS-4024, Gastrolene Plus GS-4
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and Females Adult & Paediatric who are expected to require Nasogastric Tube for naso-gastric introduction to administer enteral nutrition and also for aspiration of gastro-intestinal secretions. 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 present with medical emergency where treatment is more priority than the informed consent informed assent process. 2 Subject with intraoral growth, distorted oral anatomy head & neck cancer patients having restricted mouth opening recent nasal surgery 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 Nasogastric Tube and its components. 5 Other conditions which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with the participation in and completion of the protocol. 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 Intubation of nasal oral passage with Romolene or Nasogastric Tube clinically intended for enteral feeding purpose. 2 Facilitating clinical use for enteral feeding. 3 Facilitating clinically use for medical conditions requiring aspiration of gastric content. 4 Improving the quality of life of the subject by achieving the intended purpose. Timepoint: Use duration of device is not more than 7 days. | — |
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 Materials compatibility with the body tissue & nutritional fluids or medications.Timepoint: Use duration of device is not more than 7 days. | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed