OncologyNCT06758011
ivWatch in Prevention of Extravasation of Vesicants in an Oncology Setting
A study testing ivWatch in people with Oncology and Extravasation, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Oncology, Extravasation
- What is being tested?
- ivWatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2023to 26 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of using the ivWatch device to detect extravasations of peripheral vesicants given in an adult oncology ambulatory population.
SECONDARY OBJECTIVE:
- Evaluate the clinical outcomes of extravasations that occur with the use of the ivWatch device.
- Conditions
- Oncology, Extravasation
- Being tested
- ivWatch
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivWatchDevice
Patients wear ivWatch device at time of already scheduled chemotherapy on study.
| Study group | Role | What they receive |
|---|---|---|
| Medical Device Usage | Experimental | Patients utilize ivWatch device at time of already scheduled chemotherapy on study Receives: Device: ivWatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year
Secondary outcomes (1)
Change in number of extravasations while wearing ivWatch
Summary of patient level data will be reported
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start17 May 2023
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758011
- Sponsor's protocol ID
- I-2794222
- Status last verified
- Feb 2026
- First submitted
- 26 Dec 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for ivWatch® in Prevention of Extravasation of Vesicants in an Oncology Setting
- ClinicalTrials.gov ID
- NCT06758011
- Acronym / sponsor ID
- I-2794222
- Conditions
- Oncology, Extravasation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the feasibility of using the ivWatch device to detect extravasations of peripheral vesicants given in an adult oncology ambulatory population.
SECONDARY OBJECTIVE:
- Evaluate the clinical outcomes of extravasations that occur with the use of the ivWatch device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Device Usage | Experimental | Device: ivWatchPatients utilize ivWatch device at time of already scheduled chemotherapy on study |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ivWatchPatients wear ivWatch device at time of already scheduled chemotherapy on study. | Device | Medical Device Usage |
Primary outcome
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
1 secondary outcome
Change in number of extravasations while wearing ivWatch
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ivWatch in people with Oncology and Extravasation, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of extravasation in patients wearing ivWatch (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.