NCT06758011

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,400 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oncology
• Extravasation

Interventions

Type	Name	Description
DEVICE	ivWatch	Patients wear ivWatch device at time of already scheduled chemotherapy on study.

Timeline

• Start date: 2023-05-17
• Primary completion: 2026-01-26
• Completion: 2026-01-26
• First posted: 2025-01-03
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study