BridgeMD
BATOLISA
EU CTIS ID: 2024-513529-21-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Allergy to iodine or shellfish
- Oncologic history
- Hyperthyroïdisme
- Autonomus thyroid adenoma
- Hypersensitivity to Indocyanine green
- Skin lesions
See the full eligibility 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 </= 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.