RecruitingNAINTERVENTIONAL

Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery

This study is investigating a new surgical robot called eCential Robotics. It's designed to help surgeons place small, supportive screws in the spine very precisely during operations. Spinal surgery has improved a lot, and robots aim to make these procedures even safer and more accurate, particularly for conditions like scoliosis, a curve in the spine. By using 3D images, the robot helps doctors plan the surgery better, fitting each patient's unique body. This research aims to confirm that the eCential Robotics robot is safe, effective, and beneficial for patients having spine or pelvis surgery. The results will also help with getting the robot officially approved for wider use.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

Start

21 Nov 2025

Estimated completion

01 Nov 2028

Pedicle Screw Accuracy Robot Navigation Spine Scoliosis

What is this study about?

Spinal surgery has come a long way over the years, and new technologies are always being developed to make operations better and safer. One of these exciting new tools is a surgical robot. This study is focusing on a specific robot called the eCential Robotics system, which helps surgeons operate on the spine.

The main job of this robot in spinal surgery is to help place small screws, called pedicle screws, into the bones of the spine. These screws are really important for stabilising the spine, especially when correcting problems like scoliosis (a curved spine). The robot uses clever computer imaging, like 3D scans, to give the surgeon a very detailed picture of your spine before the operation. This helps them plan exactly where each screw should go, making the surgery more precise and potentially safer.

The team running this study wants to collect information to make sure the eCential Robotics robot is not only safe to use but also works well and provides real benefits to patients during spine and pelvis operations. The information gathered will also be used to help the robot get a special approval mark (called CE marking), which means it meets high safety and health standards for use in Europe.

Key takeaways

This study evaluates a new robot for spinal surgery.
The robot aims to make screw placement in the spine more accurate.
It could potentially improve safety and surgical outcomes.
The study includes patients aged 5 and above requiring spinal screws.
It helps gather data for the robot's official approval.
The surgeon remains fully in control during the procedure.

Who may be eligible?

To be considered for this study, you need to be at least 5 years old and be having spinal surgery at CHU Amiens Picardie where screws will be placed in your spine. Before you can join, you (or your legal guardian if you're under 16) will need to understand what the study involves and sign a consent form. You also need to be part of a social security scheme, and if you're a teenage girl who could become pregnant, you'd need a negative pregnancy test first.

There are some reasons why you wouldn't be able to join. For example, if your surgeon isn't experienced with the eCential Robotics robot, or if your surgery doesn't involve placing these specific pedicle screws, you wouldn't be suitable. Women who are pregnant, giving birth, or breastfeeding also cannot take part. Lastly, if someone is under certain legal protections or unable to make their own decisions, they also cannot join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 5 years old or older?
Are you having spinal surgery at CHU Amiens Picardie that requires screws?
Are you able to provide consent (or your guardian can for you)?
If you are a teenage girl, are you not pregnant?
Is your specific surgery using pedicle screws?
Are you not pregnant, breastfeeding, or giving birth?

Answer every question to see your result.

What does participation involve?

The study will involve you having spinal or pelvic surgery as planned by your medical team. During this surgery, the eCential Robotics robot will be used to help place the pedicle screws. There might be some extra checks or assessments during your hospital stay related to how well the robot performed. Your doctors will follow your progress after the operation to see how you are recovering and how healthy your spine is, which is part of your usual care. The total duration of your involvement would be for your surgery and standard follow-up appointments.

Potential risks and benefits

Taking part in this study means your surgery will use a new robotic system, which aims to improve the accuracy and safety of placing screws in your spine. This could potentially lead to better surgical results and a lower chance of needing another operation later. As with any surgery, there are always risks, and using new technology doesn't remove those. However, this study is designed to make sure the robot is safe and effective. You are always in control and can decide at any point that you no longer want to be part of the study, without it affecting your medical care.

Locations (1)

CHU Amiens
Verified postcode
Amiens, France· Recruiting

Common questions

What is a pedicle screw?

A pedicle screw is a small screw placed into the bones of your spine during surgery to help hold and stabilise it.

What is scoliosis?

Scoliosis is a condition where your spine has an abnormal curve, sometimes looking like an 'S' or 'C' shape.

Will the robot do the surgery by itself?

No, the robot is a tool that helps the surgeon. The surgeon is always in charge and performs the operation.

Will being in this study change my surgery much?

Your surgery will be largely the same, but the robot will be used to assist with the placement of some screws, aiming for more precision.

What is CE marking?

CE marking is a quality standard that shows a product meets European health, safety, and environmental protection standards.

How to find out more

François DEROUSSEN, MD

deroussen.francois@chu-amiens.fr 33+322087576 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.