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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2014-05-23', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of contraction in lymph vessels.', 'timeFrame': 'At baseline and after 14 days'}, {'measure': 'Pumping pressure', 'timeFrame': 'At baseline and after 14 days'}, {'measure': 'refill time', 'timeFrame': 'At baseline and after 14 days'}, {'measure': 'velocity', 'timeFrame': 'At baseline and after 14 days'}]}, 'conditionsModule': {'conditions': ['Focus of Study is: Near Infrared Fluorescence Imaging']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the use of Near Infrared Fluorescence imaging on lymphatic vessels in humans.\n\nDifferent parameters that reflect lymphatic function will be tested for intra and inter individual reproducibility.\n\nWe use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy men between the ages of 20 and 30.\n\nWhen 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.\n\nOn 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).\n\nWe investigate the activity of vessels over time, and after several interventions such as exercise, and water baths of the foot at different temperatures.\n\nThe patients are examined for approximately 4 hours and wil be examined again 14 days later.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants are young healthy males.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nExclusion Criteria:\n\n* lymphedema, edema or vascular disease.'}, 'identificationModule': {'nctId': 'NCT02154204', 'briefTitle': 'A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'orgStudyIdInfo': {'id': 'NIRF2014'}}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Department of cardiothoracic and vascular surgery, Aarhus university hospital.', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'overallOfficials': [{'name': 'Vibeke E Hjortdal, MD, PhD, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of cardiothoracic and vascular surgery, Aarhus university hospita'}, {'name': 'Jacob H Grønlund, bac. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of cardiothoracic and vascular surgery, Aarhus university hospita'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}