Infiltration of Peripheral IV TherapyNCT02123745
ivWatch Model 400: Device Validation for Infiltrated Tissues
A study testing The ivWatch Model 400 in people with Infiltration of Peripheral IV Therapy, run by ivWatch, LLC at 1 site in United States.
Trial summary
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infiltration of Peripheral IV Therapy
- What is being tested?
- The ivWatch Model 400
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent
- Pass health screen by clinician
- 18 years or older
Who cannot join
- Fail health screen
Trial locations and contacts
1 site in 1 country.
About this study
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
- Conditions
- Infiltration of Peripheral IV Therapy
- Being tested
- The ivWatch Model 400
- Keywords
- infiltration, extravasation, peripheral intravenous therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ivWatch Model 400Device
The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
| Study group | Role | What they receive |
|---|---|---|
| Infiltrated Tissue | Experimental | The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr. Receives: Device: The ivWatch Model 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red Notification Sensitivity to Infiltrated Tissues
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
Measured: After each participant has been infiltrated, an expected average of 1 hour
Secondary outcomes (4)
Yellow Notification Sensitivity to Infiltrated Tissues
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
Measured: After each participant has been infiltrated, an expected average of 1 hour
Infiltrated Volume When Red Notification Issued
The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.
Measured: After each participant has been infiltrated, an expected average of 1 hour
Infiltrated Volume When Yellow Notification Issued
The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.
Measured: After each participant has been infiltrated, an expected average of 1 hour
Significant Skin Irritation or Disruption to Skin Integrity
The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.
Measured: After each participant has been infiltrated, an expected average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infiltration of Peripheral IV TherapyStudies of the same condition, open and under way.
- 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- ivWatch, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123745
- Sponsor's protocol ID
- IVW400CS-06
- Status last verified
- May 2014
- First submitted
- 22 Apr 2014
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ivWatch Model 400: Device Validation for Infiltrated Tissues
- ClinicalTrials.gov ID
- NCT02123745
- Acronym / sponsor ID
- IVW400CS-06
- Conditions
- Infiltration of Peripheral IV Therapy
- Keywords
- infiltration, extravasation, peripheral intravenous therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- ivWatch, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Posted 27 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infiltrated Tissue | Experimental | Device: The ivWatch Model 400The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Pass health screen by clinician
- 18 years or older
Key exclusion criteria (1 listed)
- Fail health screen
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 |
|---|---|---|
| The ivWatch Model 400The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected. | Device | Infiltrated Tissue |
Primary outcome
Red Notification Sensitivity to Infiltrated Tissues
Time frame: After each participant has been infiltrated, an expected average of 1 hour
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
4 secondary outcomes
Yellow Notification Sensitivity to Infiltrated Tissues
Time frame: After each participant has been infiltrated, an expected average of 1 hour
Infiltrated Volume When Red Notification Issued
Time frame: After each participant has been infiltrated, an expected average of 1 hour
Infiltrated Volume When Yellow Notification Issued
Time frame: After each participant has been infiltrated, an expected average of 1 hour
Significant Skin Irritation or Disruption to Skin Integrity
Time frame: After each participant has been infiltrated, an expected average of 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 The ivWatch Model 400 in people with Infiltration of Peripheral IV Therapy, run by ivWatch, LLC 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 1 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 27 Jun 2014. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Red Notification Sensitivity to Infiltrated Tissues (time frame: After each participant has been infiltrated, an expected average of 1 hour). 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 27 Jun 2014.