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Completed

NCT Number: NCT06758011

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.

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Key information

Conditions

Oncology Extravasation Neoplasms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ivWatch

Device

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

Primary outcomes

  1. Detection of extravasation in patients wearing ivWatch

    Time frame: Up to 1 year

    Evaluated by the ratio of number ivWatch used for vesicant therapy over the total number of vesicant therapies for study participants

Secondary outcomes

  1. Change in number of extravasations while wearing ivWatch

    Time frame: Up to 1 year

    Summary of patient level data will be reported

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Feb 17, 2026

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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