CTRI/2022/10/046321
Completed
Phase 4
A prospective, single arm, post market clinical follow-up of Infusion Set to explore its safety and performance in Adult & Paediatric subjects in Indian Population.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: O- Medical and Surgical
- 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 (Adult \& Paediatric) who are expected to require Infusion Set.
- •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 bleeding disorder, extensive malignant skin involvement, multicoated effusions, located fluid accumulations, hepatic hydrithorax.
- •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 Infusion Set and its component(s).
- •5\.Subject who is pregnant or breast feeding.
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
To explore safety and performance of Nelaton Catheter for drainage of urine in Adult & Paediatric subjects in Indian Population.CTRI/2022/10/046346Romsons Group Private Limited100
Completed
Phase 4
A clinical study to analyze the safety and effectiveness of Endotracheal tube ( device intubated into the trachea for provision of mechanical ventilation, For maintaining an open airway) during anesthesia or ventilation procedures.CTRI/2020/01/022807Romsons Scientific Surgical Industries Pvt Ltd100
Recruiting
Phase 4
To explore safety and performance of Closed Wound Drainage System in Adult & Paediatric subjects in Indian Population.CTRI/2024/02/062232Romsons Group Private Limited
Recruiting
Phase 4
To explore the safety and performance of Extension Line & Needle Free Connector in Adult & Paediatric patients in Indian Population.Health Condition 1: O- Medical and SurgicalCTRI/2024/02/062231Romsons Group Private Limited
Recruiting
Phase 4
To explore safety and performance of Infant Feeding Tube (Feedy) in paediatric subjects in Indian population.Health Condition 1: O- Medical and SurgicalCTRI/2024/02/063337Romsons Group Private Limited