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Clinical Trials/NCT02154204
NCT02154204
Completed
Not Applicable

A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.

University of Aarhus1 site in 1 country10 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Focus of Study is: Near Infrared Fluorescence Imaging
Sponsor
University of Aarhus
Enrollment
10
Locations
1
Primary Endpoint
refill time
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to examine the use of Near Infrared Fluorescence imaging on lymphatic vessels in humans.

Different parameters that reflect lymphatic function will be tested for intra and inter individual reproducibility.

We use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy men between the ages of 20 and 30.

When the fluorescent dye "indocyanine green", has been injected into the skin on the patients feet, it will be transported through the lymph vessels, resulting in clear visualization of the vessels, using a laser and a EM-CCD camera.

On both legs we examine the frequency of vessel contraction and the velocity of lymph moving in vessels. We furthermore use several methods to quantify the vessel function such as the refill time of a vessel, (manually emptied vessel and refill time of 10 cm of a vessel), and pumping pressure (at what pressure lymph can pass a blood pressure cuff).

We investigate the activity of vessels over time, and after several interventions such as exercise, and water baths of the foot at different temperatures.

The patients are examined for approximately 4 hours and wil be examined again 14 days later.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
May 2015
Last Updated
8 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • lymphedema, edema or vascular disease.

Outcomes

Primary Outcomes

refill time

Time Frame: At baseline and after 14 days

Pumping pressure

Time Frame: At baseline and after 14 days

Frequency of contraction in lymph vessels.

Time Frame: At baseline and after 14 days

velocity

Time Frame: At baseline and after 14 days

Study Sites (1)

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