Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
594
Countries
1
Sites
1
General anaesthetic for outpatient surgery
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nimes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 11 Sep 2023 → ongoing
- Decision date (initial)
- 2024-10-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513101-31-00
- EudraCT number
- 2023-000048-50
- ClinicalTrials.gov
- NCT06082856
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
General anaesthetic for outpatient surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10021724 | Induction of anaesthesia | 100000004865 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nimes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nimes
- Address
- 4 Place Du Professeur Robert Debre, Bp 40026 Bp 40026
- City
- Nimes Cedex 9
- Postcode
- 30029
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nimes
- Contact name
- CHRISTOPHE MASSEGUIN
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nimes
- Contact name
- CHRISTOPHE MASSEGUIN
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 594 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nimes
Anesthésie, Place Du Professeur Robert Debre, 30029, Nimes Cedex 9
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 | 2023-09-11 | 2023-10-19 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | France | Acceptable 2024-10-03
|
2024-10-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-27 | France | Acceptable 2026-02-06
|
2026-02-06 |