CTRI/2022/10/046346
Completed
Phase 4
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.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Romsons Group Private Limited
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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