ivWatch in Prevention of Extravasation of Vesicants in an Oncology Setting

Not Applicable

Recruiting

• Conditions: Oncology; Extravasation

• Registration Number: NCT06758011
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

This study aims to determine the feasibility of using the ivWatch (registered trademark) device to determine if there is an infiltration at the site of a peripheral intravenous (PIV) catheter. An infiltration is when the IV fluid leaks out of a vein and into the surrounding tissue. If medication starts leaking outside the vein, it can cause damage to the surrounding tissue. Using the ivWatch device may identify leaking fluid before the nurse is able to visually observe the signs or symptoms of the leaking fluid.

Detailed Description

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of using the ivWatch device to detect extravasations of peripheral vesicants given in an adult oncology ambulatory population.

SECONDARY OBJECTIVE:

I. Evaluate the clinical outcomes of extravasations that occur with the use of the ivWatch device.

Study Timeline

• Study Start: 2023-05-17
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2024-12-26
• Study First Posted: 2025-01-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-05-17
• Study Completion: 2025-05-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2395

Inclusion Criteria

• Patients requiring a peripheral IV for infusion of vesicant or vesicant-like agents (chemotherapy, other vesicant medications).
• PIV must be inserted
• Participant (or legal representative) must understand the nature of this study and verbally consent with the Research Study Information Sheet prior to receiving any study related procedure

Exclusion Criteria

• Patients who are not getting a vesicant, irritant or vesicant like fluid infused.
• Patients who are bruised, scarred, or tattooed in the area of the PIV.
• Patients with skin integrity issues at the site of the PIV.
• Patients who are on "light precautions."
• Not for use in power injectors.
• Not for use on mediports, implanted ports, IVAD, central lines, PICC lines.
• Patients without a cancer diagnosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ratio of number of ivWatch devices used for vesicant therapy	Up to 1 year	the ratio of number of the device used for vesicant therapy over the total number of vesicant therapies for study participants

Secondary Outcome Measures

Name	Time	Method
Change in number of extravasations while wearing ivWatch	Up to 1 year	Summary of patient level data will be reported

Trial Locations

Locations (1)

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States