Overview
Sponsor-declared trial summary
Patients planned for open or percutaneous posterior spinal stabilisation with 4 or 6 pedicle screws with a diameter of 5 to 7.5 mm (inclusive), with or without concomitant posterolateral fusion, vertebral augmentation, intervertebral body fusion devices, osteotomies, and posterior decompression.
Key facts
- Sponsor
- SentryX B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 11 May 2023 → 19 Feb 2025
- Decision date (initial)
- 2024-08-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516338-37-00
- EudraCT number
- 2022-001069-11
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients planned for open or percutaneous posterior spinal stabilisation with 4 or 6 pedicle screws with a diameter of 5 to 7.5 mm (inclusive), with or without concomitant posterolateral fusion, vertebral augmentation, intervertebral body fusion devices, osteotomies, and posterior decompression.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
SentryX B.V.
- Sponsor organisation
- SentryX B.V.
- Address
- Yalelaan 54
- City
- Utrecht
- Postcode
- 3584 CM
- Country
- Netherlands
Scientific contact point
- Organisation
- SentryX B.V.
- Contact name
- Jorrit-Jan Verlaan
Public contact point
- Organisation
- SentryX B.V.
- Contact name
- Suzanne Bruins
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 6 | 1 |
| Rest of world
Switzerland
|
— | 6 | — |
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-05-11 | 2025-02-18 | 2023-05-11 | 2024-08-13 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-05 | Netherlands | Acceptable 2024-08-09
|
2024-08-09 |