ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

NCT ID: NCT02120443

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-01-31

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.

Conditions

Infiltration of Peripheral IV Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

ivWatch Model 400

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Informed consent
• Pass health screen
• 18 years or older

Exclusion Criteria

• Fail health screen

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ivWatch, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Garret Bonnema

Chief Science Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ivWatch, LLC

Williamsburg, Virginia, United States

Countries

United States

Other Identifiers

IVW400CS-05

Identifier Type: -

Identifier Source: org_study_id