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NCT02553421 · ClinicalTrials.gov registry record · NA

Optical Detection of Intravenous Infiltration:A Pilot Study

A NA study, sponsored by ivWatch.

Completed
Registry status
NA
Development phase
243
Enrollment target

NCT02553421: Completed NA study, sponsored by ivWatch.

NCT02553421 is a NA study that has completed, run by ivWatch. The registered enrollment target is 243 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02553421, a NA study, has completed, sponsored by ivWatch.

COMPLETED
Registry status
NA
Development phase
243 participants
Enrollment target

Study Summary

This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.

Primary Outcome

The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.

Interventions

  • DEVICE ivWatch Model 400

Trial Details

FieldValue
Enrollment Target 243 participants
Start Date 2015-08
Est. Completion 2016-07
Phase NA
ivWatch

8 total trials

What the finished NCT02553421 record still lists

NCT02553421 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which ivWatch Model 400 is the first listed.

NCT02553421 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02553421 about?

NCT02553421 is a clinical study titled "Optical Detection of Intravenous Infiltration:A Pilot Study". This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.

What is the current status of trial NCT02553421?

This trial is currently completed. It is a NA study. The enrollment target is 243 participants. The study started on 2015-08. Estimated completion is 2016-07.

What interventions are being tested in trial NCT02553421?

The interventions under investigation include: ivWatch Model 400 (DEVICE).

Who is sponsoring clinical trial NCT02553421?

This trial is sponsored by ivWatch, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02553421's enrollment target sits among peer trials

243 438th of 2000 higher than 1,562 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02553421, the US trial registry maintained by the National Library of Medicine. NCT02553421 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.