A prospective, single arm, multi-centric, post market clinical follow-up of Foley Balloon Catheter to explore its safety and performance in Adult & Paediatric subjects in Indian population. - NI

Romsons Group Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1.Males and Females (Adult & Paediatric) who are expected to require Foley Balloon Catheter short-term use urethral catheterization for urine drainage.
•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.

•1.Subject who present with medical emergency, where treatment is more priority than the informed consent/informed assent process.
•2.Subject with urethral trauma, urethral stricture, infection at site, severe phimosis, traumatic injury to the lower urinary tract, 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.Subject having urethral meatus / meatal stenosis.
•5.Subjects having severe phimosis.
•6.Subject having hypospadias.
•7.Subject having high-riding prostate.
•8.Any known allergy with any of the material of Foley Balloon Catheter and its component(s).
•9.Other conditions, which in the opinion of investigating doctor make the subject unsuitable for enrolment or could, interfere with his participation in, and completion of the protocol.
•10.Subject who is pregnant or breast feeding.
•11.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
•12.Participation in another research study involving an active investigation within 30 days prior to consent.

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