To explore safety and performance of Burette Type Infusion Set for administration of intravenous fluids in Adult & Paediatric subjects in Indian Population.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/10/046347

Enrollment

100

Registered

2022-10-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Burette Type Infusion Set (Pedia Drip SS-3058, Pedia Drip Plus SS-3057, Buretta SS-3068, Volufix SS-3082, Volufix Plus SS-3082P, Volumetric Set SS-3094

Eligibility

Inclusion criteria

Inclusion criteria: 1.Males and Females (Adults & Paediatrics) who are expected to require Burette Type 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

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 hydrothorax. 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 Burette Type 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.

Design outcomes

Primary

Measure	Time frame
Successful Completion of Performance TimelineTimepoint: up to 3 days/72 hours.	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactDr Anoop Batra

Romsons Group Private Limited

cta1@romsons.com9971256314

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026