Using ivWatch to prevent IV fluid leaks in cancer patients
Feasibility Study for ivWatch® in Prevention of Extravasation of Vesicants in an Oncology Setting
This study is testing whether the ivWatch device can help catch IV fluid leaks early in cancer patients receiving chemotherapy before any visible signs show up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2395 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06758011 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of the ivWatch device in detecting extravasation of vesicants in patients receiving chemotherapy in an outpatient oncology setting. The primary objective is to determine if the device can identify infiltration at the site of a peripheral intravenous catheter before visual signs appear. Additionally, the study will assess the clinical outcomes of any extravasations that occur while using the ivWatch device. Participants will be adult oncology patients requiring a peripheral IV for vesicant infusions.
Who should consider this trial
Good fit: Ideal candidates are adult oncology patients who require a peripheral IV for the infusion of vesicant or vesicant-like agents.
Not a fit: Patients not receiving vesicant medications or those with compromised skin integrity at the IV site will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce tissue damage caused by extravasation during chemotherapy treatments.
How similar studies have performed: While the use of technology to monitor IV infusions is not novel, the specific application of the ivWatch device in this context is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Buffalo, New York
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Andrew Storer
- Email: askroswell@roswellpark.org
- Phone: 8772757724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.