NCT02120443

Brief Summary

A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 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
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

June 23, 2014

Completed
Last Updated

July 2, 2014

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

April 18, 2014

Results QC Date

April 22, 2014

Last Update Submit

June 23, 2014

Conditions

Infiltration of Peripheral IV Therapy

Keywords

infiltrationextravasationperipheral intravenous 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 the Clopper-Pearson method.

    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 monitored a common peripheral IV site over a 24 hour observation period.

Device: ivWatch Model 400

Interventions

ivWatch Model 400DEVICE

The ivWatch Model 400 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

Results Point of Contact

Title
Garret T. Bonnema
Organization
ivWatch, LLC
garret.bonnema@ivwatch.com
1.855.489.2824

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Science Officer

Study Record Dates

First Submitted

April 18, 2014

First Posted

April 22, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 2, 2014

Results First Posted

June 23, 2014

Record last verified: 2014-06

Locations

US(1)