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Clinical Trials/EUCTR2013-004954-58-DK
EUCTR2013-004954-58-DK
Active, not recruiting
Phase 1

ear infrared imaging and measurement of extremity lymphatic collector function using indocyanine green - Fluorescence lymphangiography with ICG

Bispebjerg University Hospital0 sites40 target enrollmentFebruary 12, 2014
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ConditionsHealthy volunteersMedDRA version: 19.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - InvestigationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
DrugsICG-PULSION(R)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Healthy volunteers
Sponsor
Bispebjerg University Hospital
Enrollment
40
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 12, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Bispebjerg University Hospital

Eligibility Criteria

Inclusion Criteria

  • •1\.Healthy.
  • •2\.Capable.
  • •3\.Age 18\-65 years.
  • •4\.Normal BMI range (18\-25 kg/m2 ).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 40
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Any known disease.
  • •2\.Any chronic medication.
  • •3\.Pregnancy or lactation. A negative urine\-HCG pregnancy test on the day of participation is mandatory for fertile women subjects.
  • •4\.Contraindications to the use of ICG\-PULSION® as specified in the Summary of Product Characteristics provided by the manufacturer (Pulsion Medical Systems AG)
  • •5\.Smoking or other nicotine chronic use.
  • •6\.Clinical signs of oedema (pitting, swelling), venous insufficiency (pigmentation, dermatosclerosis, wounds) or local inflammation (erythema, swelling, warm skin).

Outcomes

Primary Outcomes

Not specified

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