Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
158
Countries
1
Sites
3
Anaesthesia during free flap reconstruction surgery of the breast.
Key facts
- Sponsor
- Institut Curie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Dec 2022 → ongoing
- Decision date (initial)
- 2024-05-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513308-32-00
- EudraCT number
- 2022-001139-98
- ClinicalTrials.gov
- NCT05439005
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Anaesthesia during free flap reconstruction surgery of the breast.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Curie
- Sponsor organisation
- Institut Curie
- Address
- 26 Rue D Ulm
- City
- Paris
- Postcode
- 75005
- Country
- France
Scientific contact point
- Organisation
- Institut Curie
- Contact name
- Mary SAAD
Public contact point
- Organisation
- Institut Curie
- Contact name
- Mary SAAD
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 158 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Curie
Anesthésie, 35 Rue Dailly, 92210, Saint-Cloud
Institut Gustave Roussy
Anesthésie, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Curie
Anesthésie, 26 Rue D Ulm, 75005, Paris
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 |
|---|---|---|---|---|---|
| France | 2022-12-07 | 2022-12-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-01 | France | Acceptable 2024-05-02
|
2024-05-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-04 | France | Acceptable 2025-02-21
|
2025-02-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-03 | France | Acceptable 2025-12-22
|
2025-12-22 |