NCT02552420

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

4.8 years

First QC Date

July 28, 2015

Last Update Submit

September 15, 2015

Conditions

Keywords

infrared thermal imagingdeep venous thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 24 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients can not be good partners,
  • Doctors believe that there is any inappropriate situations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2015

First Posted

September 17, 2015

Study Start

September 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-09