Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-05 @ 6:16 PM
Study NCT ID:
NCT02154204
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2014-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: