Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
132
Countries
1
Sites
1
Cyclops syndrome
Key facts
- Sponsor
- Ramsay Generale De Sante, Groupement de Coopération Sanitaire Ramsay Santé pour l’Enseignement et la Recherche
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 18 Jul 2024 → 10 Jul 2025
- Decision date (initial)
- 2024-05-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509193-32-01
- ClinicalTrials.gov
- NCT05008731
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cyclops syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10058029 | Arthrofibrosis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ramsay Generale De Sante
- Sponsor organisation
- Ramsay Generale De Sante
- Address
- 39 Rue Mstislav Rostropovitch
- City
- Paris
- Postcode
- 75017
- Country
- France
Scientific contact point
- Organisation
- Groupement de Coopération Sanitaire Ramsay Santé pour l’Enseignement et la Recherche
- Contact name
- LOCRET
Public contact point
- Organisation
- Groupement de Coopération Sanitaire Ramsay Santé pour l’Enseignement et la Recherche
- Contact name
- LOCRET
Groupement de Coopération Sanitaire Ramsay Santé pour l’Enseignement et la Recherche
- Sponsor organisation
- Groupement de Coopération Sanitaire Ramsay Santé pour l’Enseignement et la Recherche
- Address
- 39 rue Mstislav Rostropovitch
- City
- Paris
- Postcode
- 75017
- Country
- France
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 132 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-07-18 | 2024-07-18 | 2025-07-10 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-05 | France | Acceptable 2024-04-22
|
2024-05-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-25 | France | Acceptable 2024-10-31
|
2024-12-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-17 | France | Acceptable 2025-04-07
|
2025-04-11 |