ivWatch in Prevention of Extravasation of Vesicants in an Oncology Setting

Feasibility Study for ivWatch® in Prevention of Extravasation of Vesicants in an Oncology Setting

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.

Study Overview

• Status: Completed
• Conditions: Oncology; Extravasation
• Intervention / Treatment: Device: ivWatch

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 Type: Interventional
• Enrollment (Actual): 2400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical Device Usage; Patients utilize ivWatch device at time of already scheduled chemotherapy on study	Device: ivWatch; Patients wear ivWatch device at time of already scheduled chemotherapy on study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of extravasation in patients wearing ivWatch	Evaluated by the ratio of number ivWatch used for vesicant therapy over the total number of vesicant therapies for study participants	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of extravasations while wearing ivWatch	Summary of patient level data will be reported	Up to 1 year

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Actual): January 26, 2026
• Study Completion (Actual): January 26, 2026

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): January 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: I-2794222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes