ivWatch in Prevention of Extravasation of Vesicants in an Oncology Setting

NCT06758011 | Completed FDA Device

• 1 other identifier: I-2794222
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Extravasation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in number of extravasations while wearing ivWatch

  Up to 1 year

Study Arms (1)

Medical Device Usage

EXPERIMENTAL

Patients utilize ivWatch device at time of already scheduled chemotherapy on study

Device: ivWatch

Interventions

ivWatch DEVICE

Patients wear ivWatch device at time of already scheduled chemotherapy on study.

Medical Device Usage

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: May 17, 2023
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)