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NCT02137148 Clinical Trial

Sonic Window Study Evaluation Plan

Non-palpable Veins Clinical Trial

Official title:
Observational Study of the Sonic Window Handheld Ultrasound System for Assistance With Vascular Access and Needle Placement

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02137148
Other study ID # E-14-542
Secondary ID
Status Withdrawn
Phase N/A
First received May 12, 2014
Last updated March 2, 2015
Start date June 2014
Est. completion date January 2015

Study information
Verified date March 2015
Source Analogic Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The goals of this study are as follows; evaluation of the products' readiness to market, ascertain initial reactions by target users, evaluate actual use in potential clinical settings and any difficulties encountered with product use and actual venous cannulation.

Description:

This study was cancelled

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patient Requires needle placement

Exclusion Criteria:

- Under 18 years of age

- Needle placement not required.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Use of Ultrasound to assist in needle placement
Use of the Sonic Window handheld Ultrasound device to assist in needle placement by providing a coronal image of the patient anatomy.

Locations
Country Name City State
United States Englewood Hospital & Medical Center Englewood New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Analogic Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary First Stick Success With this study we want to confirm that The Sonic Window aids in locating and accessing non-palpable veins in a group of up to 50 patients. 10 minutes No