Deep Venous ThrombosisNCT02552420
The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism
An observational study of Deep Venous Thrombosis, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
The purpose of this study is to determine the effectiveness of infrared thermal imaging in adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Venous Thrombosis
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Jul 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: DVT patients included in this study had been definitively diagnosed as having DVT with CPUS and/or angiography. Included non-DVT volunteers were confirmed to be without DVT with CPUS. The healthy volunteer group matched the DVT group in number, age, and gender.
Who may be able to join
- Willing to participate in the trial and sign the informed consent form,
- Aged: 18-75 years. They had been definitively diagnosed with venous thromboembolism,
- The bed-rest immobilization time should be more than 72 hours,
- Planing to gynecology operation,
- The D dimer should be more than500 g • L-1,
- There is no obvious symptoms of systemic infection two weeks before the test,
- There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (chest and lower limbs),
- There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases.
Who cannot join
- Patients can not be good partners,
- Doctors believe that there is any inappropriate situations.
About this study
The purpose of this study is to determine the effectiveness of infrared thermal imaging in adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT).
- Conditions
- Deep Venous Thrombosis
- Keywords
- infrared thermal imaging, deep venous thrombosis
- Medical subject headings
- Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Using the Infrared Thermal Imaging to detecting Venous Thromboembolism
① Different levels of pseudocode (white, red, pink, yellow, green, blue, black) representing related IRTI that corresponds to a color scale bar of low to high temperatures, so we can know disease's position, extent and severity by comparing with the difference of color distribution and shape in the thermal imaging.
②The intensity of thermal distribution is higher than normals (great than or equal 0.5 Celsius degree is unnoraml), the symmetry of thermal range is relatively increased (pixels over 0.5 ~ 1.0-fold), the difference of spatial distribution of the thermal field and the difference of statistically analyze are related to the disease.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2007
- Primary completionJul 2012
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangge Deng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552420
- Sponsor's protocol ID
- GIRD
- Status last verified
- Sep 2015
- First submitted
- 28 Jul 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT02552420
- Acronym / sponsor ID
- GIRD
- Conditions
- Deep Venous Thrombosis
- Keywords
- infrared thermal imaging, deep venous thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Sep 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.
The purpose of this study is to determine the effectiveness of infrared thermal imaging in adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT).
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- DVT patients included in this study had been definitively diagnosed as having DVT with CPUS and/or angiography. Included non-DVT volunteers were confirmed to be without DVT with CPUS. The healthy volunteer group matched the DVT group in number, age, and gender.
Key inclusion criteria (8 listed)
- Willing to participate in the trial and sign the informed consent form,
- Aged: 18-75 years. They had been definitively diagnosed with venous thromboembolism,
- The bed-rest immobilization time should be more than 72 hours,
- Planing to gynecology operation,
- The D dimer should be more than500 g • L-1,
Key exclusion criteria (2 listed)
- Patients can not be good partners,
- Doctors believe that there is any inappropriate situations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Using the Infrared Thermal Imaging to detecting Venous Thromboembolism
Time frame: up to 24 months
① Different levels of pseudocode (white, red, pink, yellow, green, blue, black) representing related IRTI that corresponds to a color scale bar of low to high temperatures, so we can know disease's position, extent and severity by comparing with the difference of color distribution and shape in the thermal imaging. ②The intensity of thermal distribution is higher than normals (great than or equal 0.5 Celsius degree is unnoraml), the symmetry of thermal range is relatively increased (pixels over 0.5 ~ 1.0-fold), the difference of spatial distribution of the thermal field and the difference of statistically analyze are related to the disease.
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 17 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Venous Thrombosis, run by The First Affiliated Hospital of Guangzhou Medical University.
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 8 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: finished, as of the sponsor's last update on 17 Sep 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 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?
Using the Infrared Thermal Imaging to detecting Venous Thromboembolism (time frame: up to 24 months). 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 17 Sep 2015.