Milky Way Sensor Motion Validation

NCT ID: NCT07228416

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infiltration of Peripheral IV Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Non-Infiltrated Tissue

The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.

Group Type EXPERIMENTAL

ivWatch Model 400

Intervention Type DEVICE

The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.

Interventions

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ivWatch Model 400

The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ivWatch, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jason Naramore CTO, MS

Role: CONTACT

(855) 489-2824

Marisa Brown, BS

Role: CONTACT

(855) 489-2824

Other Identifiers

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IVW-CLR-CS37-400

Identifier Type: -

Identifier Source: org_study_id

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