Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
9
Countries
1
Sites
1
Lymphedema
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Toulouse
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2026-05-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Lymphedema
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Toulouse
- Sponsor organisation
- Centre Hospitalier Universitaire De Toulouse
- Address
- 2 Rue Viguerie
- City
- Toulouse
- Postcode
- 31300
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- principal investigator
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- clinical research project manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 9 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
vascular medicine, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-08 | France | Acceptable 2026-05-18
|
2026-05-18 |