A prospective, single arm, post market clinical follow-up of Nelaton Catheter to explore its safety and performance in Adult & Paediatric subjects in Indian Population.

Romsons Group Private Limited0 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 (Adults & Paediatrics) who are expected to require Nelaton Catheter (Nel Cath).
•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 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.

•1.Subject who present with medical emergency, where treatment is more priority than the informed consent/informed assent process.
•2.Subject with a history of urethral stricture, undergone trans-urethral resection of the prostate gland in the previous 48 hours, subject with phimosis, undiagnosed hematuria, urinary tract infection with clinical symptoms, dysuria due to urethral stricture, 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 Nelaton Catheter (Nel Cath) and its component(s).
•5.Other conditions, which in the opinion of investigator make the subject unsuitable for enrolment or could, interfere with his/her participation in, and completion of the clinical investigation plan.
•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.

发起方