A prospective, single arm, post market clinical follow-up study of Endotracheal Tube to evaluate safety and performance in Indian population.

Romsons Scientific Surgical Industries Pvt Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年1月22日

试验速览

暂无简介。

•1. Males and Females above 18 year expected to require mechanical ventilation.
•2. Subject who can provide informed consent form in writing and medically in a position to undergo consent and screening process.
•3. The subject is willing and able to comply with the requirement of the study protocol.

•1. Subject who present with medical emergency, where treatment is more priority than the informed consent process.
•2. Subject, who cannot provide informed consent in general such as unconscious, mentally challenged patient, vulnerable subject etc.
•3. Allergy with any of the material of Endotracheal Tube and its component.
•4. Subject who is pregnant or breastfeeding.
•5. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
•6. Participation in another research study involving an investigational agent within 30 days prior to consent.

发起方

Romsons Scientific Surgical Industries Pvt Ltd