Any Condition Requiring a PICC PlacementNCT01232933
Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
A study testing VPS System in people with Any Condition Requiring a PICC Placement, run by VasoNova, Inc. at 1 site in United States.
Trial summary
Subjects meeting study requirements will be consented and have their PICC catheter placed using navigational technology and the tip placement confirmed with radiographic imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Condition Requiring a PICC Placement
- What is being tested?
- VPS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with a PICC placement order
Who cannot join
- Pregnant or nursing
- Abnormal ECG
- Anatomic irregularities or history that would prevent proper placement
- Subject does not consent to photography, release of data and x-ray confirmation
- Subject does not understand or is not willing to sign informed consent for the VPS implant procedure and data release
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Subjects meeting study requirements will be consented and have their PICC catheter placed using navigational technology and the tip placement confirmed with radiographic imaging.
- Conditions
- Any Condition Requiring a PICC Placement
- Being tested
- VPS System
- Keywords
- PICC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPS SystemDevice
Use of the navigational VPS system during catheter placement
| Study group | Role | What they receive |
|---|---|---|
| VPS System | Experimental | Use of navigational VPS system to place catheter Receives: Device: VPS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance target: the catheter tip will be located in the lower 1/3 of the SVC or at the cavoatrial junction as evaluated by fluoroscopy with a VPS bullseye at least 90% of the time
Measured: participants are followed until catheter tip confirmation via fluoroscopy is completed which is on average one hour from procedure initiation
Secondary outcomes (1)
The VPS will provide a blue bullseye indicator 80-90% of the time
Measured: participants are followed until catheter tip confirmation is completed which is on average one hour from the start of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Condition Requiring a PICC PlacementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- VasoNova, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232933
- Sponsor's protocol ID
- TP-0120
- Status last verified
- Nov 2010
- First submitted
- 15 Jun 2010
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
- ClinicalTrials.gov ID
- NCT01232933
- Acronym / sponsor ID
- TP-0120
- Conditions
- Any Condition Requiring a PICC Placement
- Keywords
- PICC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- VasoNova, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 2 Nov 2010 (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.
Subjects meeting study requirements will be consented and have their PICC catheter placed using navigational technology and the tip placement confirmed with radiographic imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VPS System | Experimental | Device: VPS SystemUse of navigational VPS system to place catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult with a PICC placement order
Key exclusion criteria (5 listed)
- Pregnant or nursing
- Abnormal ECG
- Anatomic irregularities or history that would prevent proper placement
- Subject does not consent to photography, release of data and x-ray confirmation
- Subject does not understand or is not willing to sign informed consent for the VPS implant procedure and data release
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 |
|---|---|---|
| VPS SystemUse of the navigational VPS system during catheter placement | Device | VPS System |
Primary outcome
Performance target: the catheter tip will be located in the lower 1/3 of the SVC or at the cavoatrial junction as evaluated by fluoroscopy with a VPS bullseye at least 90% of the time
Time frame: participants are followed until catheter tip confirmation via fluoroscopy is completed which is on average one hour from procedure initiation
1 secondary outcome
The VPS will provide a blue bullseye indicator 80-90% of the time
Time frame: participants are followed until catheter tip confirmation is completed which is on average one hour from the start of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPS System in people with Any Condition Requiring a PICC Placement, run by VasoNova, Inc. 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 5 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: finished, as of the sponsor's last update on 2 Nov 2010. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance target: the catheter tip will be located in the lower 1/3 of the SVC or at the cavoatrial junction as evaluated by fluoroscopy with a VPS bullseye at least 90% of the time (time frame: participants are followed until catheter tip confirmation via fluoroscopy is completed which is on average one hour from procedure initiation). 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 2 Nov 2010.