Study of the pressure into the lymphatic vessels in healthy people, detremined with the help of the near-infrared fluoroscopy

Conditions: lymphatic pressure in upper limb from healthy volunteers
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2014-002501-38-BE

Lead Sponsor: B - Unité de Recherche en Lymphologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Healthy volunteers
- Written informed consent signed

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 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Coronary disease
- Pregnancy
- Allergy to iodine or to shellfish
- Breastfeeding
- Advanced renal impairment
- Minors
- Thyroid pathology
- Primary and secondary lymphedema anywhere on the body
- Oncologic history
- Familial lymphedema
- Previous surgery on the studied member, causing risk of a subclinical lymphedema

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To study the influence of an applied pressure on this upper limb on the progression of the lymph in this limb, using a sphygmomanometer.<br>- To determine the occlusion pressure of superficial lymphatic vessels from the upper limb of healthy volunteers, from the previous observations.<br>;Secondary Objective: - To show the superficial lymphatic network of the upper limb from healthy volunteers, with the help of lymphofluoroscopy, after subcutaneous injection of Indocyanine Green (ICG) in the first interdigital space of the studied limb.<br>;Primary end point(s): - To study the influence of an applied pressure on this upper limb on the progression of the lymph in this limb, using a sphygmomanometer.<br>- To determine the occlusion pressure of superficial lymphatic vessels from the upper limb of healthy volunteers, from the previous observations.<br>;Timepoint(s) of evaluation of this end point: after observation and image analysis for each patient

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - To show the superficial lymphatic network of the upper limb from healthy volunteers, with the help of lymphofluoroscopy, after subcutaneous injection of Indocyanine Green (ICG) in the first interdigital space of the studied limb.<br>;Timepoint(s) of evaluation of this end point: after observation and image analysis for each patient