NCT04065373

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

August 20, 2019

Last Update Submit

August 20, 2019

Conditions

Infiltration of Peripheral IV Therapy

Outcome Measures

Primary Outcomes (1)

  • Normal Tissue Red Notification Rate

    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 negative binomial regression model.

    24 Hours

Secondary Outcomes (2)

  • Normal Tissue Yellow Notification Rate

    24 Hours

  • Significant Skin Irritation or Disruption to Skin Integrity

    24 Hours

Study Arms (1)

Non-Infiltrated Tissue

EXPERIMENTAL

The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored a common peripheral IV site over a 24 hour observation period.

Device: ivWatch Model 400 with SmartTouch and fiber optic sensor

Interventions

ivWatch Model 400 with SmartTouch and fiber optic sensorDEVICE

The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored tissue at common IV sites over a 24 hour period.

Non-Infiltrated Tissue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Pass health screen
  • years or older

You may not qualify if:

  • Fail health screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ivWatch, LLC

Williamsburg, Virginia, 23185, United States

Location

Study Officials

  • Marisa Cole

    Employee

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

April 25, 2019

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

US(1)