Measurement of lymphatic vessel function using fluorescence imaging

Phase 1

• Conditions: Healthy volunteers; MedDRA version: 19.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2013-004954-58-DK
• Lead Sponsor: Bispebjerg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-12
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified