The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism

Deep Venous Thrombosis Clinical Trial

Official title:

The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552420
• Other study ID #: GIRD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 28, 2015
• Last updated: September 15, 2015
• Start date: September 2007
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 2015
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Willing to participate in the trial and sign the informed consent form,

2. Aged: 18-75 years. They had been definitively diagnosed with venous thromboembolism,

3. The bed-rest immobilization time should be more than 72 hours,

4. Planing to gynecology operation,

5. The D dimer should be more than500 g • L-1,

6. There is no obvious symptoms of systemic infection two weeks before the test,

7. There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (chest and lower limbs),

8. There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases.

Exclusion Criteria:

1. Patients can not be good partners,

2. Doctors believe that there is any inappropriate situations.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Using the Infrared Thermal Imaging to detecting Venous Thromboembolism	? 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.; ?The 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.	up to 24 months	Yes