Trial Outcomes & Findings for Milky Way Sensor Motion Validation (NCT NCT07228416)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

24 Hours

Results posted on

2026-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Infiltrated Tissue The ivWatch Model 400 with Milky Way Sensor monitored a common peripheral IV site over a 24 hour observation period.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Infiltrated Tissue n=20 Participants The ivWatch Model 400 with Milky Way Sensor monitored a common peripheral IV site over a 24 hour observation period.
Age, Continuous	48 years n=20 Participants
Sex: Female, Male Female	13 Participants n=20 Participants
Sex: Female, Male Male	7 Participants n=20 Participants

PRIMARY outcome

Timeframe: 24 Hours

Population: Check IV notifications are counted per day for each research subject

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.

Outcome measures

Outcome measures
Measure	Non-Infiltrated Tissue n=20 Participants The ivWatch Model 400 with Milky Way Sensor monitored a common peripheral IV site over a 24 hour observation period.
Red Check IV Notification Rate Per Day	0.208 Check IV notifications per day Interval 0.078 to 0.553

Adverse Events

Non-Infiltrated Tissue

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason Naramore

ivWatch

Phone: 8554892824

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place