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Tests treatment safety and results for Cervical Spine Disease
Official title Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
ClinicalTrials.gov ID: NCT06960018
What this study is testing
- What it's testing
- The study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical approach using the Ennovate® Cervical Spinal System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All patients with minimum 18 years of age receiving Ennovate® Cervical internal fixation device within the vertebral bodies C2-Th3 to ensure the...
You likely can't join if
- All patients not willing to sign the patient consent are excluded. Also, if it is clear from the beginning, that the patient will not be able to come...
- Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant components; for example, osteopenia...
- Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant system.
- Suspected allergy or sensitivity to the implant materials.
- Acute or chronic vertebral infections of a local or systemic nature.
- Poor patient compliance or limited ability to follow medical instructions, particularly in the postop phase, including with regard to the...
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, Germany
- Berlin, Germany
- Freiburg im Breisgau, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, Germany; Berlin, Germany; Freiburg im Breisgau, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.