A prospective, single arm, post market clinical follow-up of Yankaur Suction Set & Accessories (Vaccu Suck Suction Set & Accessories) 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 Yankaur Suction Set & Accessories (Vaccu Suck Suction Set & Accessories) to explore safety and performance in subject who are requiring per-operative suction & removal of surgical debris, secretions, blood. 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 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The Primary End Point of the study are as
时间窗: Short Term Use
1 Successful per-operative removal of surgical debris-secretions blood by suctioning.
时间窗: Short Term Use
2 Facilitating per-operative removal of surgical debris blood secretions from the operative site successfully by use the device.
时间窗: Short Term Use
3 Improving the visibility & clarity at the surgical site during the surgical operation.
时间窗: Short Term Use
4 Vent port modifiable to provide thumb control during suctioning.
时间窗: Short Term Use
次要结局
- The Secondary End Point of the study are as(1 Device material compatibility with the body tissues and fluids.)
研究者
Dr S Srivishnu
Valentis Cancer Hospital