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

The occlusion pressure of superficial lymphatics in the upper extremity of healthy volunteers: A Near infrared lymphofluoroscopy approach

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002501-38-BE

Enrollment

Registered

2015-01-16

Start date

2015-07-08

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymphatic pressure in upper limb from healthy volunteers

Interventions

Trade Name: Indocyanine Green PULSION 25 mg Product Name: Indocyanine Green 25mg Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: INDOCYANINE GREEN CAS Number: 3599-32-4 Oth

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. - To determine the occlusion pressure of superficial lymphatic vessels from the upper limb of healthy volunteers, from the previous observations. ;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. ;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. ;Timepoint(s) of evaluation of this end point: after observation and image analysis for each patient	—

Measure

Time frame

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. - To determine the occlusion pressure of superficial lymphatic vessels from the upper limb of healthy volunteers, from the previous observations. ;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. ;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. ;Timepoint(s) of evaluation of this end point: after observation and image analysis for each patient

—

Secondary

Measure	Time frame
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. ;Timepoint(s) of evaluation of this end point: after observation and image analysis for each patient	—

Countries

Belgium

Contacts

Public ContactJean-Paul Belgrado

ULB - Unité de Recherche en Lymphologie

belgrado@ulb.ac.be0032475633434

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026