NCT02137148

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

May 12, 2014

Last Update Submit

March 2, 2015

Conditions

Non-palpable Veins

Keywords

Vascular AccessSonic WindowUltrasound

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Use of Ultrasound to assist in needle placementDEVICE

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

Also known as: Sonic Window, SW1000

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 adults who require vascular access

You may qualify if:

  • Patient Requires needle placement

You may not qualify if:

  • Under 18 years of age
  • Needle placement not required.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Englewood Hospital & Medical Center

Englewood, New Jersey, 07631, United States

Location

Study Officials

  • Arveh Shander, M.D.

    EHMC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 13, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations

US(1)