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NCT07259811
Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration
NA trial testing VCFix Spinal System in stand-alone configuration in Vertebral Compression Fracture in 10 participants. Participants enrolled and being followed up; not accepting new ones.
14 May 2026
Quick facts
| Lead sponsor | Amber Implants B.V. |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 18 September 2023 |
| Primary completion | 14 May 2026 |
| Estimated completion | 14 May 2026 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- VCFix Spinal System in stand-alone configuration
Conditions studied
- Vertebral Compression Fracture — all drugs for Vertebral Compression Fracture →
Sponsor
Amber Implants B.V.
Who can join
Adults 22 to 85, any sex, with Vertebral Compression Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and works well in early testings, so that a larger safety study can be done later to help get CE approval. The VCFix Spinal System will be used in its independent setup, within its planned use for treatment of vertebral compression fracture. It's designed to be a small early study to test safety and see if the treatment idea is possible, with one group and no blinding. Two hospitals in EU will enroll in total 10 participants with a single vertebral fracture that will undergo the same surgery. The main test goals are: how successful the access creation of the vertebral body is using the VCFix Preparation kit according to the provided instructions, how successful the positioning of the VCFix implant is by using the VCFix Implantation kit according to the provided instructions, and how successful the fracture reduction by expanding the VCFix implant according to the provided instructions. The main safety goal is: number of device-/procedure-related major side effects through 30 days after the initial procedure. Participant enrollment will last around 12 months. Each participant will be followed for 2 years after the implantations. All side effects related to the spine will be documented throughout the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07259811
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of VCFix Spinal System in stand-alone configuration
Trials testing the same drug.
- NCT07301749 — A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fr · NA · recruiting
Other recruiting trials for Vertebral Compression Fracture
Currently open trials in the same condition.
- NCT07301749 — A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fr · NA · recruiting
- NCT04835428 — STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures · NA · recruiting
- NCT04821739 — RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures · NA · recruiting
- NCT07507565 — Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty vs Thermal Facet Ablation · NA · active not recruiting
Other Amber Implants B.V. trials
Trials by the same sponsor.
- NCT07301749 — A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fr · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07259811 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amber Implants B.V.
- Last refreshed: 2 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07259811.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing