Extravasation of Contrast MediaAVERT-PLUSNCT02434055
Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS
An observational study of Extravasation of Contrast Media, run by Anand Prasad.
Trial summary
Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures. Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during angiography… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extravasation of Contrast Media
- What is being tested?
- AVERT PLUS
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with cardiovascular disease undergoing clinically indicated coronary or peripheral angiography
Who may be able to join
- subjects aged 18 or older with cardiovascular disease scheduled to undergo clinically indicated coronary or peripheral angiography who give informed consent to participate.
Who cannot join
- None
About this study
Official title: Evaluation of a Novel Method of Contrast Volume Quantification - The AVERT PLUS
Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures.
Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during angiography (coronary or peripheral) and a concomitant system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contract volume used during clinically indicated angiography in the cardiac catheterization laboratory.
Read the detailed description
Thirty consecutive subjects who consent to participate and are undergoing planned angiography will be enrolled. The AVERT PLUS is a system which is external to the patient and connected to the control syringe that the physician uses to deliver the contrast dye to the patient. For each injection that the physician performs, the starting syringe volume, the ending syringe volume, and the net contrast delivered to the patient will be recorded. At the same time, the net volume delivered to the patient will also be recorded from the AVERT PLUS console. For each injection, these two sets of variables will be compared to determine accuracy of the AVERT PLUS to quantify net contrast volume used.
- Conditions
- Extravasation of Contrast Media
- Being tested
- AVERT PLUS
- Medical subject headings
- Extravasation of Diagnostic and Therapeutic Materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVERT PLUSDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedure
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Business purposes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extravasation of Contrast MediaStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anand Prasad
- Sponsor type
- University, hospital or other
- Collaborators
- Osprey Medical, Inc
- Responsible party
- Sponsor-investigator, Anand Prasad, The University of Texas Health Science Center at San Antonio
- Investigators
- Michele Shepard, Study director, Osprey Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434055
- Sponsor's protocol ID
- HSC20150190H
- Acronym
- AVERT-PLUS
- Status last verified
- Jun 2015
- First submitted
- 29 Apr 2015
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Method of Contrast Volume Quantification - The AVERT PLUS
- ClinicalTrials.gov ID
- NCT02434055
- Acronym / sponsor ID
- AVERT-PLUS / HSC20150190H
- Conditions
- Extravasation of Contrast Media
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business purposes
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Anand PrasadUniversity, hospital or other
- Collaborators
- Osprey Medical, Inc
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 May 2015 (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.
Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures.
Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during angiography (coronary or peripheral) and a concomitant system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contract volume used during clinically indicated angiography in the cardiac catheterization laboratory.
Detailed description
Thirty consecutive subjects who consent to participate and are undergoing planned angiography will be enrolled. The AVERT PLUS is a system which is external to the patient and connected to the control syringe that the physician uses to deliver the contrast dye to the patient. For each injection that the physician performs, the starting syringe volume, the ending syringe volume, and the net contrast delivered to the patient will be recorded. At the same time, the net volume delivered to the patient will also be recorded from the AVERT PLUS console. For each injection, these two sets of variables will be compared to determine accuracy of the AVERT PLUS to quantify net contrast volume used.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with cardiovascular disease undergoing clinically indicated coronary or peripheral angiography
Key inclusion criteria (1 listed)
- subjects aged 18 or older with cardiovascular disease scheduled to undergo clinically indicated coronary or peripheral angiography who give informed consent to participate.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AVERT PLUS | Device | – |
Primary outcome
Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedure
Time frame: During procedure
Results and safety
The study was stopped early (reason given: Business purposes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
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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.
Michele Shepard study director
Osprey Medical, Inc
Questions about this trial
What is this clinical trial studying?
An observational study of Extravasation of Contrast Media, run by Anand Prasad.
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 1 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: stopped early, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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 stopped early (reason given: Business purposes). Results are not available in the source record.
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?
Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedure (time frame: During procedure). 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 18 Jun 2015.