To explore safety and performance of Bi-Valve (Three-way Stop Cock) used with infusion line and pressure monitoring in Indian Population.

Not Applicable

Completed

• Conditions: Persons encountering health services in other circumstances,

• Registration Number: CTRI/2021/04/032495
• Lead Sponsor: Romsons Scientific and Surgical Industries Pvt Ltd

Brief Summary

This is a prospective, single arm, post-market clinical follow-up of Bi-Valve (Three-way stop cock) to explore safety and performance in Indian population.

**Inclusion Criteria**

**1.**Males and Females above 18 years who are expected to require simultaneous infusions, intermittent drug injections, blood samplings, central venous pressure measurements, arterial add-on devices used for invasive pressure measurements, blood sampling/s, flushing with normal saline, etc.

**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.**Any planned therapy of corrosive medications, photosensitive medication and highly viscous fluids.

**3.**Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc.

**4.**Any known allergy of material of Three-way stop cock and its component.

**5.**Other conditions, which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with his participation in, and completion of the protocol.

**6.**Subject who is pregnant or breastfeeding.

**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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-04
• Study Completion: 2024-10-02
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Males and Females above 18 years who are expected to require simultaneous infusions, intermittent drug injections, blood samplings, central venous pressure measurements, arterial add-on devices used for invasive pressure measurements, blood sampling/s, flushing with normal saline, etc.
• 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.Any planned therapy of corrosive medications, photosensitive medication and highly viscous fluids.
• 3.Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc.
• 4.Any known allergy of material of Three-way stop cock and its component.
• 5.Other conditions, which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with his participation in, and completion of the protocol.
• 6.Subject who is pregnant or breastfeeding.
• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful completion of performance timeline	Not Beyond 5 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