Focus of Study is: Near Infrared Fluorescence ImagingNCT02154204
A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.
An observational study of Focus of Study is: Near Infrared Fluorescence Imaging, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Focus of Study is: Near Infrared Fluorescence Imaging
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to May 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The participants are young healthy males.
Who may be able to join
None listed.
Who cannot join
- lymphedema, edema or vascular disease.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of cardiothoracic and vascular surgery, Aarhus university hospital.
Aarhus N, 8200
About this study
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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of contraction in lymph vessels.
Measured: At baseline and after 14 days
Pumping pressure
Measured: At baseline and after 14 days
refill time
Measured: At baseline and after 14 days
velocity
Measured: At baseline and after 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study is: Near Infrared Fluorescence ImagingStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vibeke E Hjortdal, MD, PhD, DMSc, Study director, Department of cardiothoracic and vascular surgery, Aarhus university hospitaJacob H Grønlund, bac. med., Principal investigator, Department of cardiothoracic and vascular surgery, Aarhus university hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154204
- Sponsor's protocol ID
- NIRF2014
- Status last verified
- May 2014
- First submitted
- 23 May 2014
- Last updated
- 29 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.
- ClinicalTrials.gov ID
- NCT02154204
- Acronym / sponsor ID
- NIRF2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Jun 2014 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants are young healthy males.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- lymphedema, edema or vascular disease.
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
Frequency of contraction in lymph vessels.
Time frame: At baseline and after 14 days
Pumping pressure
Time frame: At baseline and after 14 days
refill time
Time frame: At baseline and after 14 days
velocity
Time frame: At baseline and after 14 days
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 29 Jun 2017.
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.
Vibeke E Hjortdal, MD, PhD, DMSc study director
Department of cardiothoracic and vascular surgery, Aarhus university hospita
Jacob H Grønlund, bac. med. principal investigator
Department of cardiothoracic and vascular surgery, Aarhus university hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus of Study is: Near Infrared Fluorescence Imaging, run by University of Aarhus at 1 site in Denmark.
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 0 inclusion and 1 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 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Frequency of contraction in lymph vessels. (time frame: At baseline and after 14 days). The study lists 4 primary outcomes in all. 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 29 Jun 2017.