A prospective, single arm, post market clinical follow-up of Closed Wound Drainage System to explore its 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 Closed Wound Drainage System to evaluate its safety and performance in subjects who will undergo surgery/ closed wound drainage procedures. 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 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 undergo surgery closed wound drainage procedures 2 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.
- •3 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.
排除标准
- •1 Subject who present with medical emergency where treatment is more priority than the informed consent process informed assent process 2 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 3 Any known allergy with any of the material of Closed Wound Drainage System and its components 4 Other conditions which in the opinion of investigators make the patient unsuitable for enrollment or could interfere with his her participation in and completion of the clinical investigation plan protocol 5 Subject who is pregnant or breastfeeding 6 Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital 7 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: Device maximum use duration is not more than 7 days
1 Intended for Closed Wound Drainage
时间窗: Device maximum use duration is not more than 7 days
2 Facilitating drainage from the Closed wound site by catheter
时间窗: Device maximum use duration is not more than 7 days
3 Angulated sharp tipped trocar needle for easy penetration and placement of drainage catheter
时间窗: Device maximum use duration is not more than 7 days
4 Application of optimum negative pressure by flexible bellow jar chamber
时间窗: Device maximum use duration is not more than 7 days
5 Facilitating the precise drained volume determination in follow-up from closed wound
时间窗: Device maximum use duration is not more than 7 days
6 Improving the quality of life by reduction of symptoms
时间窗: Device maximum use duration is not more than 7 days
7 Achieving the intended clinical purpose
时间窗: Device maximum use duration is not more than 7 days
次要结局
- The Secondary End Point of the study are as(1 Device material compatibility with the tissue and body fluids)
研究者
Dr S Srivishnu
Valentis Cancer Hospital