To explore safety and performance of Infant Feeding Tube (Feedy) in paediatric subjects in Indian population.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/02/063337
- Lead Sponsor
- Romsons Group Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Paediatrics male and female who are expected to require enteral nutrition feeding introduction of fluids etc. in paediatrics whose parents legal guardians are willing to provide written informed assent form will be eligible for inclusion in the follow-up.
2 Subjects parent LAR Legally Acceptable Representative can provide Informed Assent Form Child.
3 Parents or legal guardians must be able to complete all relevant follow-up procedures during follow-up participation.
1 Subject who present with medical emergency where treatment is more priority than the informed assent process.
2 Subjects paediatrics with severe malabsorption intestinal obstruction.
3 History of any reaction or hypersensitivity likely to be exacerbated by any components of the Infant Feeding Tube or Feedy.
4 Subject with congenital defect or serious chronic illness.
5 Other conditions which in the opinion of investigators make the subject unsuitable for enrolment or could interfere with his participation in and completion of the clinical investigation plan.
6 Participation in another research study involving an active investigation within 30 days prior to consent.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Primary End Point of the study are as <br/ ><br>1 Intubation of nasal or oral passage with Infant Feeding Tube clinically intended for enteral feeding purpose. <br/ ><br>2 Facilitating clinical use for enteral feeding. <br/ ><br>3 Facilitating clinical use for medical conditions requiring aspiration of gastric content. <br/ ><br>4 Improving the quality of life of the subject by achieving the intended purpose.Timepoint: Device maximum use duration is not more than 7 days.
- Secondary Outcome Measures
Name Time Method The Secondary End Point of the study are as <br/ ><br>1 Durability sustainability & device fixation with standard combination devices required the clinical use. <br/ ><br>2 Device material compatibility with the body tissue & also with nutritional fluids or medications. <br/ ><br>Timepoint: Device maximum use duration is not more than 7 days.