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A clinical study to analyze the safety and effectiveness of Intra Cath-2 (I.V Cannula) during infusion therapy in Indian population

A prospective, single arm, post market clinical follow-up of Intra Cath-2 (I.V Cannula) to explore safety and performance in Indian population.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/03/031852
Enrollment
100
Registered
2021-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: Z768- Persons encountering health services in other specified circumstances

Interventions

Intervention1: Intra Cath-2 (I.V Cannula): The device Intra Cath-2 (I.V Cannula) is an intravenous access device required for intravenous infusion therapy Control Intervention1: Not applicable: Not ap

Sponsors

Romsons Scientific and Surgical Industries Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Males and Females above 18 year expected to require intravenous peripheral infusion therapy. 2.Subject who can provide informed consent form in writing and medically in a position to undergo consent and screening process. 3.The subject 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 process. 2.Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc. 3.Allergy with any of the material of Intra Cath-2 (I.V Cannula) and its component. 4.Subject who is pregnant or breastfeeding. 5. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. 6.Participation in another research study involving an active investigation within 30 days prior to consent.

Design outcomes

Primary

MeasureTime frame
Successful completion of performance timelineTimepoint: 1. Less than 3 Days 2. Greater than 3 Days

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactMr Vijay Arora

Romsons Scientific & Surgical Industries Pvt. Ltd.

cro@romsons.com8574610157

Outcome results

None listed

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