Vital Peripheral Intravenous Catheter Feasibility (ViTAL-PIVC)

Embrace Medical Ltd.

Status: Completed

Conditions: Catheterization, Peripheral Venous

Treatments: Device: GPIV

Study type: Interventional

Funder types: Industry

Identifiers

NCT07016607

CLP-001

Details and patient eligibility

About

The goal of this clinical trial is to assess the safety and efficacy of ViTal, a peripheral intravenous catheter with a glide-on-contact design of the plastic canula tip, in peripheral intravenous catheterization in individuals requiring intravenous therapy or blood sampling. The main question it aims to answer is:

What is the first attempt success rate of the peripheral intravenous catheterization done using the study device?

Participants will be asked to grade the pain they experienced when attempts were made to insert the study device into their peripheral vein.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female age ≥ 18.
2. Requiring blood sample collection (roll-in subjects) or planned for PIVC (analyzable subjects)
3. Signed informed consent.

Exclusion criteria

1. Pregnancy or lactation.
2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement).
3. Previous venous grafts or surgery at the target vessel access site.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

GPIV

Experimental group

Description:

If the eligibility criteria are fulfilled, up to 4 attempts will be made to achieve successful peripheral intravenous catheterization with the investigational device. All successive attempts will be made at a site different from the one(s) at which access has already failed.

Treatment:

Device: GPIV