Non-palpable VeinsNCT02137148
Sonic Window Study Evaluation Plan
An observational study of Non-palpable Veins, run by Analogic Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-palpable Veins
- What is being tested?
- Use of Ultrasound to assist in needle placement
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 adults who require vascular access
Who may be able to join
- Patient Requires needle placement
Who cannot join
- Under 18 years of age
- Needle placement not required.
Trial locations and contacts
1 site in 1 country.
United States1 site
Englewood Hospital & Medical Center
Englewood, New Jersey, 07631
About this study
Official title: Observational Study of the Sonic Window Handheld Ultrasound System for Assistance With Vascular Access and Needle Placement
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.
Read the detailed description
This study was cancelled
- Conditions
- Non-palpable Veins
- Being tested
- Use of Ultrasound to assist in needle placement
- Keywords
- Vascular Access, Sonic Window, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Ultrasound to assist in needle placementDevice
Also called Sonic Window, SW1000
Use of the Sonic Window handheld Ultrasound device to assist in needle placement by providing a coronal image of the patient anatomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Study was cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-palpable VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Analogic Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arveh Shander, M.D., Principal investigator, EHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137148
- Sponsor's protocol ID
- E-14-542
- Status last verified
- Mar 2015
- First submitted
- 12 May 2014
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Sonic Window Handheld Ultrasound System for Assistance With Vascular Access and Needle Placement
- ClinicalTrials.gov ID
- NCT02137148
- Acronym / sponsor ID
- E-14-542
- Conditions
- Non-palpable Veins
- Keywords
- Vascular Access, Sonic Window, Ultrasound
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Analogic CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was cancelled
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 adults who require vascular access
Key inclusion criteria (1 listed)
- Patient Requires needle placement
Key exclusion criteria (2 listed)
- Under 18 years of age
- Needle placement not required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Ultrasound to assist in needle placementAlso: Sonic Window, SW1000Use of the Sonic Window handheld Ultrasound device to assist in needle placement by providing a coronal image of the patient anatomy. | Device | – |
Primary outcome
First Stick Success
Time frame: 10 minutes
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arveh Shander, M.D. principal investigator
EHMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-palpable Veins, run by Analogic Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Stick Success (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.