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

Not Applicable

Completed

• Conditions: Persons encountering health services in other specified circumstances,

• Registration Number: CTRI/2021/03/031852
• Lead Sponsor: Romsons Scientific and Surgical Industries Pvt Ltd

Brief Summary

This is a prospective, post marketing clinical follow-up of Intra Cath-2 (Intravenous (IV) Cannula) to explore safety and performance in subject who requiring intravenous peripheral infusion therapy.

**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:-**

**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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Study Completion: 2024-04-27
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful completion of performance timeline	1. Less than 3 Days | 2. Greater than 3 Days

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1)

Pushpanjali Hospital & Research Center Pvt Ltd; 🇮🇳 Agra, UTTAR PRADESH, India

Pushpanjali Hospital & Research Center Pvt Ltd

🇮🇳Agra, UTTAR PRADESH, India

Dr Rohit Jain

Principal investigator

9628273135

dr.rohitjain85@gmail.com