Overview
Sponsor-declared trial summary
Lipedema
Until today lipedema diagnosis is based on the evaluation of a body of non-specific clinical signs. Studies so far have centered around the weakness of collagen. Lipoedema patients have a tortuous superficial venous network probably due to the fragility of collagen type 3 involved in the architecture of the different v…
Key facts
- Sponsor
- Universite Libre de Bruxelles
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Phenomena and Processes [G] - Physiological processes [G07]
- Trial duration
- 24 Jan 2025 → 16 Jan 2026
- Decision date (initial)
- 2024-08-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Lipedema Foundation, CT, USA
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Until today lipedema diagnosis is based on the evaluation of a body of non-specific clinical signs. Studies so far have centered around the weakness of collagen. Lipoedema patients have a tortuous superficial venous network probably due to the fragility of collagen type 3 involved in the architecture of the different vessels. Superficial lymphatic vessels are normally porous but in lipedema patients this porosity seems to be augmented. The main objective of the study is to compare the porosity of the superficial lymphatic vessels of women with lipedema vs healthy subjects so as to determine the adequacy of ICG lymph-fluoroscopy as a diagnostic tool.
Secondary objectives 2
- To evaluate the motricity and the pumping force of the superficial limphatic collectors by comparing lipedema patients vs healthy subjects.
- To measure the occlusion pressure of the superficial lymphatic collectors (below 160mmHg).
Conditions and MedDRA coding
Lipedema
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10063955 | Lipoedema | 100000004861 |
| 20.0 | LLT | 10063956 | Lipedema | 10027433 |
| 20.0 | LLT | 10063956 | Lipedema | 10027433 |
| 21.1 | PT | 10063955 | Lipoedema | 100000004861 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2014-002501-38 | The occlusion pressure of superficial lymphatics in the upper extremity of healthy volunteers: A Near infrared lymphofluoroscopy approach | |
| 2013-001360-36 | Evaluation of the benefit of lymphofluoroscopy in the validation of the manual drainage techniques on lymphedema, Evaluation de l'intérêt de la lymphofluoroscopie dans la validation des techniques de drainage manuel des lymphoedèmes | |
| 2015-000588-15 | The occlusion pressure of superficial lymphatics in the lower extremity of healthy volunteers: A Near infrared lymphofluoroscopy approach |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Inclusion criteria for LIPEDEMA PATIENTS: 1. Women
- Age: 18-50 y.o. (non-menopausal)
- Signed informed consent form
- BMI: 18-30
- Waist to hip ration </= 0.7
- Easy bruising
- Pain level (VAS) >/=4
- Lipedema syndrome diagnosed by a health professional
- Inclusion criteria HEALTHY SUBJECTS - 1-4 AS ABOVE (1. women; 2. age: 18-50 (non menopausal); 3. BMI: 18-300; 4. Signed informed consent form
Exclusion criteria 14
- Allergy to iodine or shellfish
- Male subjects
- Menopause or perimenopause period
- Pregnancy
- Breastfeeding
- Refusal and/or incapacity to give informed consent form
- Advanced renal impairment
- Known coagulation disorders
- Use of anticoagulants
- Oncologic history
- Hyperthyroïdisme
- Autonomus thyroid adenoma
- Hypersensitivity to Indocyanine green
- Skin lesions
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. To observe the fluorescence in the extracellular matrix surrounding the superficial lymphatic vessels.
Secondary endpoints 2
- To quantify the mean velocity of the bolus displacement between two reference points placed over the collectors 50mm apart.
- 2. To measure the occlusion pressure of the superficial lymphatic collectors (below 160mmHg).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
VERDYE 5 mg/ml poudre pour solution injectable
PRD10944430 · Product
- Active substance
- Indocyanine Green
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRADERMAL
- Max daily dose
- 0.5 mg/kg milligram(s)/kilogram
- Max total dose
- 5 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CX01 — -
- Marketing authorisation
- BE274671
- MA holder
- DIAGNOSTIC GREEN LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Fluorescent contrast agent off-label intradermal use at concentrations of 0.08mg of VERDYE in 0.4ml of H2O. The concentrations applied to the examined anatomical area are 100 times lower than those used in the other applications of the product. The aim of this application is to visualize the superficial lymphatics with Near Infra-Red Fluorescence Imaging (NIRFI).
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universite Libre de Bruxelles
- Sponsor organisation
- Universite Libre de Bruxelles
- Address
- Lennikse Baan 808
- City
- Anderlecht
- Postcode
- 1070
- Country
- Belgium
Scientific contact point
- Organisation
- Universite Libre de Bruxelles
- Contact name
- Jean-Paul Belgrado
Public contact point
- Organisation
- Universite Libre de Bruxelles
- Contact name
- Jean-Paul Belgrado
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-01-24 | 2026-01-16 | 2025-01-24 | 2026-01-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 28 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ProtocolBATOLISA | 1 |
| Protocol (for publication) | ProtolBATOLISA Version2 English | 2 |
| Protocol (for publication) | ProtolBATOLISA Version2 English Clean | 2 |
| Protocol (for publication) | ProtolBATOLISA Version2 Neederlands | 2 |
| Protocol (for publication) | ProtolBATOLISA Version2 Neederlands Clean | 2 |
| Protocol (for publication) | ProtolBATOLISAVersion2 French | 2 |
| Protocol (for publication) | ProtolBATOLISAVersion2 French Clean | 2 |
| Protocol (for publication) | ProtolBATOLISAVersion2 German | 2 |
| Protocol (for publication) | ProtolBATOLISAVersion2 German Clean | 2 |
| Recruitment arrangements (for publication) | PatientRecruitment | 1 |
| Subject information and informed consent form (for publication) | AEPatientProtocol | 1 |
| Subject information and informed consent form (for publication) | ICF CTIS Final German clean | 2 |
| Subject information and informed consent form (for publication) | ICF CTIS Final Neerl clean | 2 |
| Subject information and informed consent form (for publication) | ICF CTIS Final English Clean | 2 |
| Subject information and informed consent form (for publication) | ICF CTIS Final English with answers to collumn remark | 2 |
| Subject information and informed consent form (for publication) | ICF CTIS Final French back GB | 2 |
| Subject information and informed consent form (for publication) | ICF CTIS Final French clean | 2 |
| Subject information and informed consent form (for publication) | ICF French version 3 | 3 |
| Subject information and informed consent form (for publication) | InformedConsentICGen | 1 |
| Subject information and informed consent form (for publication) | InformedConsentICGen fr | 1 |
| Subject information and informed consent form (for publication) | InformedConsentICGnl | 1 |
| Subject information and informed consent form (for publication) | Recommendations | 1 |
| Subject information and informed consent form (for publication) | Recommendations nl | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | VerdyeAssessment | 1 |
| Synopsis of the protocol (for publication) | Synopsis de | 1 |
| Synopsis of the protocol (for publication) | Synopsis fr | 1 |
| Synopsis of the protocol (for publication) | Synopsis nl | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-09 | Belgium | Acceptable with conditions 2024-08-07
|
2024-08-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-20 | Belgium | Acceptable with conditions 2024-08-07
|
2024-12-20 |