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NCT04065373 · ClinicalTrials.gov registry record · NA

ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

A NA study, sponsored by ivWatch.

Completed
Registry status
NA
Development phase
45
Enrollment target

NCT04065373: Completed NA study, sponsored by ivWatch.

NCT04065373 is a NA study that has completed, run by ivWatch. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04065373, a NA study, has completed, sponsored by ivWatch.

COMPLETED
Registry status
NA
Development phase
45 participants
Enrollment target

Study Summary

A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch SmartTouch and fiber optic sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Primary Outcome

The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using a

Interventions

  • DEVICE ivWatch Model 400 with SmartTouch and fiber optic sensor

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2019-04-25
Est. Completion 2019-06-21
Phase NA
ivWatch

8 total trials

What the finished NCT04065373 record still lists

NCT04065373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

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

NCT04065373 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04065373 about?

NCT04065373 is a clinical study titled "ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues". A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch SmartTouch and fiber optic sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

What is the current status of trial NCT04065373?

This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2019-04-25. Estimated completion is 2019-06-21.

What interventions are being tested in trial NCT04065373?

The interventions under investigation include: ivWatch Model 400 with SmartTouch and fiber optic sensor (DEVICE).

Who is sponsoring clinical trial NCT04065373?

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

How this trial's enrollment target compares

Where NCT04065373's enrollment target sits among peer trials

45 1411th of 2000 higher than 578 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 NCT04065373, the US trial registry maintained by the National Library of Medicine. NCT04065373 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.