NCT07228416

Brief Summary

A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 12, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 12, 2025

Last Update Submit

November 13, 2025

Conditions

Infiltration of Peripheral IV Therapy

Keywords

motion

Outcome Measures

Primary Outcomes (1)

  • Check IV notification rate per day

    The ivWatch Model 400 issues Check IV 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

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:

  • years of age or older
  • Healthy individual, verified by an eligible designation on the Health History Form

You may not qualify if:

  • Currently enrolled in another clinical trial
  • Currently pregnant or trying to become pregnant
  • Serious and uncontrolled medical condition
  • Tattoo(s), scarring, or bruising that severely limits vein visualization at a sensor monitoring location
  • Medical adhesive allergy
  • Sleepwalking occurrence in the last year
  • Current drug/alcohol dependence
  • Sick or had an infection in the last 14 days
  • Hospitalized in the last 14 days
  • Fever at the time of study visit (≥100.4°F)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Jason Naramore CTO, MS

CONTACT

(855) 489-2824jason.naramore@ivwatch.com

Marisa Brown, BS

CONTACT

(855) 489-2824marisa.brown@ivwatch.com

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

November 12, 2025

First Posted

November 14, 2025

Study Start

December 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

November 14, 2025

Record last verified: 2025-11