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NCT05489822 · ClinicalTrials.gov registry record
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
A clinical trial of Trauma and Degenerative Disc Disease (DDD), sponsored by Silony Medical.
- Recruiting
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT05489822 is a study of Trauma and Degenerative Disc Disease (DDD) that is actively recruiting participants, run by Silony Medical. The registered enrollment target is 20 participants, below the 307-participant average among 56 other Trauma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05489822, a study of Trauma and Degenerative Disc Disease (DDD), is actively recruiting participants, sponsored by Silony Medical.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). Primary Objective: To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire. Primary endpoint hypothesis: The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.
Conditions Studied
Interventions
- DEVICE VERTICALE® Cervical System
Study Locations (1)
Illinois
- University of Illinois Hospital and Health Sciences System - UI Health - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-01-13 |
| Est. Completion | 2026-04 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05489822
The ClinicalTrials.gov registry entry for NCT05489822 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 307-participant average among 56 other Trauma trials with a reported enrollment target (93% lower). The listed sponsor is Silony Medical, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Trauma appearing as the primary indexed condition, and to 1 intervention - of which VERTICALE® Cervical System is the first listed.
NCT05489822 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT05489822 about?
NCT05489822 is a clinical study titled "PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.". In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spin...
What is the current status of trial NCT05489822?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2023-01-13. Estimated completion is 2026-04.
What conditions does trial NCT05489822 study?
This clinical trial studies the following conditions: Trauma, Degenerative Disc Disease (DDD), Deformity, Instabilities.
What interventions are being tested in trial NCT05489822?
The interventions under investigation include: VERTICALE® Cervical System (DEVICE).
Who is sponsoring clinical trial NCT05489822?
This trial is sponsored by Silony Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05489822 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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