Venous ThromboembolismPAFCNCT02735759
Detecting Circulating Emboli in Patients with Acute Venous Thromboembolism
A study testing Photoacoustic flow cytometry device in people with Venous Thromboembolism, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to further evaluate and adjust the photoacoustic flow cytometry device and its use in detecting circulating emboli. Study Design: Cohort 1: Normal healthy volunteers will be enrolled to further adjust the device settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Photoacoustic flow cytometry device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Jul 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Willing to adhere to protocol.
- Signed informed consent
- Ages 18 years and older
- Confirmed new diagnosis of acute venous thromboembolism.
- performance status of equal to or less than 2.
Show all 9Show fewer
- Able to receive anticoagulation therapy.
- Willing to adhere to specific protocol requirements.
- Signed informed consent.
Who cannot join
- Unable to provide informed consent.
- History of venous thromboembolism.
- Currently receiving anticoagulant therapy.
- Life threatening venous thromboembolism.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Detecting Circulating Emboli in Patients with Acute Venous Thromboembolism Using in Vivo Photoacoustic Flow Cytometry (PAFC)
The purpose of this study is to further evaluate and adjust the photoacoustic flow cytometry device and its use in detecting circulating emboli.
Study Design: Cohort 1: Normal healthy volunteers will be enrolled to further adjust the device settings. Cohort 2: Use the Phatoacoustic flow cytometry (PAFC) to detect circulating emboli in vivo in patients with venous thromboembolism at diagnosis, during and after anticoagulation therapy.
Read the detailed description
Laser beam from the investigational device Phatoacoustic flow cytometry PAFC will be applied to skin and underlying blood vessels. The optical and ultrasound signal will be collected for analysis. On each tested vessel, we will estimate the vessels diameter (using optical or/and ultrasound imaging). The subject's skin pigmentation will be classified as light, medium, or dark. A photoacoustic (PA) contrast will be considered usable for detection of circulating emboli if the photoacoustic signal from the vessels is more than 1.3-fold higher than the photoacoustic signal from surrounding tissue. The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. D-dimer test will be performed on each time point as part of their normal standard of care however if the D-dimer test is not ordered as part of the standard of care it will be required for the study.. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.
- Conditions
- Venous Thromboembolism
- Being tested
- Photoacoustic flow cytometry device
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic flow cytometry deviceDevice
The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | This cohort will consist of ten healthy volunteers. The photoacoustic flow cytometry device will be used to establish device settings. The intervention with the subject will include the PAFC device to establish appropriate device settings. Receives: Device: Photoacoustic flow cytometry device |
| Venous Thromboembolism | Other | This cohort will consist of ten patients with newly diagnosed, non-life threatening acute venous thromboembolism. The intervention with the subjects is to perform the photoacoustic flow cytometry device to detect circulating emboli in vivo in patients with venous thromboembolism at diagnosis, during and after anticoagulation therapy. Receives: Device: Photoacoustic flow cytometry device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects that posses circulating emboli.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start1 Jul 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: Required revisions were unable to be made to protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhifu Xiang, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735759
- Sponsor's protocol ID
- 205341.
- Acronym
- PAFC
- Status last verified
- Jul 2018
- First submitted
- 1 Apr 2016
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data learned from this study will be published.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Circulating Emboli in Patients with Acute Venous Thromboembolism Using in Vivo Photoacoustic Flow Cytometry (PAFC)
- ClinicalTrials.gov ID
- NCT02735759
- Acronym / sponsor ID
- PAFC / 205341.
- Conditions
- Venous Thromboembolism
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Required revisions were unable to be made to protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 13 Apr 2016 (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 purpose of this study is to further evaluate and adjust the photoacoustic flow cytometry device and its use in detecting circulating emboli.
Study Design: Cohort 1: Normal healthy volunteers will be enrolled to further adjust the device settings. Cohort 2: Use the Phatoacoustic flow cytometry (PAFC) to detect circulating emboli in vivo in patients with venous thromboembolism at diagnosis, during and after anticoagulation therapy.
Detailed description
Laser beam from the investigational device Phatoacoustic flow cytometry PAFC will be applied to skin and underlying blood vessels. The optical and ultrasound signal will be collected for analysis. On each tested vessel, we will estimate the vessels diameter (using optical or/and ultrasound imaging). The subject's skin pigmentation will be classified as light, medium, or dark. A photoacoustic (PA) contrast will be considered usable for detection of circulating emboli if the photoacoustic signal from the vessels is more than 1.3-fold higher than the photoacoustic signal from surrounding tissue. The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. D-dimer test will be performed on each time point as part of their normal standard of care however if the D-dimer test is not ordered as part of the standard of care it will be required for the study.. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Device: Photoacoustic flow cytometry deviceThis cohort will consist of ten healthy volunteers. The photoacoustic flow cytometry device will be used to establish device settings. The intervention with the subject will include the PAFC device to establish appropriate device settings. |
| Venous Thromboembolism | Other | Device: Photoacoustic flow cytometry deviceThis cohort will consist of ten patients with newly diagnosed, non-life threatening acute venous thromboembolism. The intervention with the subjects is to perform the photoacoustic flow cytometry device to detect circulating emboli in vivo in patients with venous thromboembolism at diagnosis, during and after anticoagulation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years and older
- Willing to adhere to protocol.
- Signed informed consent
- Ages 18 years and older
- Confirmed new diagnosis of acute venous thromboembolism.
Key exclusion criteria (4 listed)
- Unable to provide informed consent.
- History of venous thromboembolism.
- Currently receiving anticoagulant therapy.
- Life threatening venous thromboembolism.
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 |
|---|---|---|
| Photoacoustic flow cytometry deviceThe device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year. | Device | Healthy Volunteers, Venous Thromboembolism |
Primary outcome
Number of subjects that posses circulating emboli.
Time frame: One year
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 3 Sep 2024.
- Individual participant dataSharing planned: Yes. Data learned from this study will be published.
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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.
Zhifu Xiang, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoacoustic flow cytometry device in people with Venous Thromboembolism, run by University of Arkansas 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 9 inclusion and 4 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 3 Sep 2024. 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?
Number of subjects that posses circulating emboli. (time frame: One year). 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 3 Sep 2024.