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OpenTrials
Completed

NCT Number: NCT07016607

Vital Peripheral Intravenous Catheter Feasibility

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.

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Key information

Conditions

Catheterization, Peripheral Venous

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Canela

La Romana, Dominican Republic

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

GPIV

Device

The investigational device is a peripheral intravenous catheter with a passive fully automatic needlestick protection, with a glide-on-contact design of the plastic cannula tip featuring asymmetry, with the negative, convex slope in the plane perpendicular to the longitudinal axis of the tip resulting in bottom part of the cannula being shorter.

Other names: ViTal

Primary outcomes

  1. First attempt success rate

    Time frame: Periprocedural

    Proportion, in percent, of subjects with successful peripheral intravenous catheterization Successful PIVC is defined as withdrawal of non-pulsatile blood or infusion of saline without evidence of extravasation.

    Failed PIVC is defined as extravasation with initial infusion, inability to draw blood, physician or nurse intervention for access or inability to obtain access.

Secondary outcomes

  1. Device- and procedure-related adverse events

    Time frame: Periprocedural

    Incidence of the device- and procedure-related adverse events

Sponsors and collaborators

Lead sponsor

Embrace Medical Ltd.

Industry

Registry information

Official study title

Feasibility Study to Assess the Safety and Efficacy of the ViTal Peripheral Intravenous Catheter

Acronym: ViTAL-PIVC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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