E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
lymphatic pressure in upper limb from healthy volunteers |
|
E.1.1.1 | Medical condition in easily understood language |
study of the pressure in the lymphatic vessel of healthy people (without lymphedema) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To study the influence of an applied pressure on this upper limb on the progression of the lymph in this limb, using a sphygmomanometer.
- To determine the occlusion pressure of superficial lymphatic vessels from the upper limb of healthy volunteers, from the previous observations.
|
|
E.2.2 | Secondary objectives of the trial |
- 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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Healthy volunteers
- Written informed consent signed
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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.
- To determine the occlusion pressure of superficial lymphatic vessels from the upper limb of healthy volunteers, from the previous observations.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after observation and image analysis for each patient |
|
E.5.2 | 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.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
after observation and image analysis for each patient |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
after Imaging the upper limb of the last patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |