Vital Peripheral Intravenous Catheter Feasibility

NCT07016607 | Completed

• 1 other identifier: CLP-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheterization, Peripheral Venous

Outcome Measures

Primary Outcomes (1)

• First attempt success rate

  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.

  Periprocedural

Secondary Outcomes (1)

• Device- and procedure-related adverse events

  Periprocedural

Study Arms (1)

GPIV

EXPERIMENTAL

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.

Device: GPIV

Interventions

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.

Also known as: ViTal

GPIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Embrace Medical Ltd.: lead

Study Sites (1)

Clinica Canela

La Romana, Dominican Republic

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 11, 2025
• Study Start: November 22, 2021
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)