A prospective, single arm, post market clinical follow-up of Nasogastric Tube to explore safety and performance in Adult & Paediatric subjects in Indian Population.
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Primary End Point of the study are as
研究概览
简要总结
This is a prospective, post marketing clinical follow-up of Nasogastric Tube to explore safety and performance in subjects who are expected to require Nasogastric Tube for naso-gastric introduction to administer enteral nutrition and also for aspiration of gastro-intestinal secretions. Investigators and their team will be responsible for recruitment and ethical conduct of the follow-up. As per inclusion & exclusion criteria, subjects will be included in this follow-up. An informed consent / informed assent will be obtained from all subjects who are potential follow-up candidates prior to commencement of any follow-up related procedure.
All data will be collected in the follow-up specific Case Report Form.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The Primary End Point of the study are as
时间窗: Use duration of device is not more than 7 days.
1 Intubation of nasal oral passage with Romolene or Nasogastric Tube clinically intended for enteral feeding purpose.
时间窗: Use duration of device is not more than 7 days.
2 Facilitating clinical use for enteral feeding.
时间窗: Use duration of device is not more than 7 days.
3 Facilitating clinically use for medical conditions requiring aspiration of gastric content.
时间窗: Use duration of device is not more than 7 days.
4 Improving the quality of life of the subject by achieving the intended purpose.
时间窗: Use duration of device is not more than 7 days.
次要结局
- 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.)
研究者
Dr Sanjay Kala
GSVM Medical College