BATOLISA
Phase 1
- Conditions
- ipoedema, LipedemaMedDRA version: 21.1Level: PTClassification code: 10063955Term: Lipoedema Class: 100000004861MedDRA version: 20.0Level: LLTClassification code: 10063956Term: Lipedema Class: 10027433Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Therapeutic area: Phenomena and Processes [G] - Physiological processes [G07]Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2024-513529-21-00
- Lead Sponsor
- niversite Libre de Bruxelles
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
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 /=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
Allergy to iodine or shellfish, Oncologic history, Hyperthyroïdisme, Autonomus thyroid adenoma, Hypersensitivity to Indocyanine green, Skin lesions, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method