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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/04/032495

Enrollment

100

Registered

2021-04-01

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: Z69-Z76- Persons encountering health services in other circumstances

Interventions

Intervention1: Bi-Valve (Three-way stop cock): Bivalve (Three-Way Stop Cock) is intended for use with infusion line for the selective running of one or two paths intravenous line also used for pressur

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Successful completion of performance timelineTimepoint: Not Beyond 5 days	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactMr Vijay Arora

Romsons Scientific & Surgical Industries Pvt. Ltd.

cta2@romsons.com9389319931

Outcome results

None listed

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