Health TrialsbyHealthPanel

Milky Way Sensor: Device Validation for Infiltrated Tissues

ConditionInfiltration of Peripheral IV Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorivWatch, LLC

About this trial

A single arm trial consisting of 28 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years of age or older

Healthy, verified by an eligible designation on the Health History Form

Disqualifiers

Abnormal bleeding / hemophilia

Absence of sensation in one or both arms

Allergy to common medical materials

Blood clotting disorder

Trial design

Design model

Single group

Treatments tested in this trial

  • ivWatch Model 400 with Milky Way Sensor

    Device

    The ivWatch Model 400 with Milky Way Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Infiltrated TissueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Red Notification Sensitivity to Infiltrated Tissues

The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.

Time frame
After each participant has been infiltrated, an expected average of 1 hour.

Secondary outcomes

1

Yellow Notification Sensitivity to Infiltrated Tissues

The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.

Time frame
After each participant has been infiltrated, an expected average of 1 hour.
2

Significant Skin Irritation or Disruption to Skin Integrity

The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.

Time frame
After each participant has been infiltrated, an expected average of 1 hour.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ivWatch, LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: