Pedicle Screw AccuracyRobotec AmiensNCT07421752
Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery
A study testing eCential Robotics solution in people with Pedicle Screw Accuracy and Robot, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Spinal surgery has evolved considerably over the years, and the introduction of advanced technologies has played a crucial role in improving clinical outcomes. The use of surgical robots, such as the eCential Robotic system, has emerged as an innovative solution for optimizing the precision and safety of procedures… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Pedicle Screw Accuracy, Robot, Navigation
- What is being tested?
- eCential Robotics solution
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 5 years or older.
- Treated at CHU Amiens Picardie for spinal surgery requiring implantation of pedicle screws.
- Informed consent signed by patient or legal representative and child.
- Membership of a social security scheme.
- Negative pregnancy test for adolescent women of childbearing age
Who cannot join
- Patient managed by a practitioner with no experience of the eCential Robotics robot.
- Patient requiring a technique without implantation of pedicle screws.
- Patients already suffering from deterministic radiation effects
- Pregnant, parturient or breast-feeding women.
- Patients under guardianship or curators, under safeguard of justice or deprived under public law.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Francois Deroussen, MD, (33)322087576, deroussen.francois@chu-amiens.fr
Richard Gouron, Pr
About this study
Official title: Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery at Amiens Picardie University Hospital
Spinal surgery has evolved considerably over the years, and the introduction of advanced technologies has played a crucial role in improving clinical outcomes. The use of surgical robots, such as the eCential Robotic system, has emerged as an innovative solution for optimizing the precision and safety of procedures, particularly the placement of pedicle screws in the spine.
The eCential Robotics surgical robot offers several advantages for the placement of pedicle screws in the spine. Various studies have demonstrated a significant improvement in screw accuracy and stability, reducing revision surgery rates with surgical robots. The system enables advanced preoperative planning based on three-dimensional imaging, improving understanding of the patient's specific anatomy. This study will also provide a clinical basis for the CE marking process.
The objective of this prospective study is to collect data confirming safety, performance and clinical benefits of the eCential Robotics robot when used during spine and pelvic surgeries.
- Conditions
- Pedicle Screw Accuracy, Robot, Navigation, Spine, Scoliosis
- Being tested
- eCential Robotics solution
- Keywords
- Pedicle screw accuracy, robot, navigation, spine, scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCential Robotics solutionProcedure or surgery
The robotic aid is adaptable to all cannulated pedicle screw implantations in spine surgery. The eCential Robotics solution consists of a unified platform combining 2D/3D imaging, navigation and robotics.
The procedure consists of :
- Setting up the patient reference on the patient's spinal processes
- 2D then 3D imaging (low-dose technology, using a 5-axis motorized X-ray C-arm to optimize trajectory and increase reconstruction volume)
- Intraoperative planning of implants based on the patient's image in the operating position
- Navigation: automatic matching of patient and 3D imagery with factory pre-calibrated single-use instruments. Real-time visualization of the trajectory in the 3D image.
- Robotic surgery: collaborative robot-surgeon handling. Automatic alignment of pedicle aiming instruments with workflow control from the sterile zone.
- 3D imaging to control screw positioning
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale
Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale. perfect intra-pedicular localization without any cortical breach (Grade A)
- < 2 mm pedicle breach (Grade B)
- < 4 mm pedicle breach (Grade C)
- < 6 mm pedicle breach (Grade D)
- ≥ 6 mm pedicle breach (Grade E) Screws graded A and B are clinically acceptable, screws graded C, D, E have a significant deviation from the intended trajectory.
Measured: 12 months
Secondary outcomes (10)
Per-operative Blood loss (ml)
Measured: day 0
Per-operative Operative time (min)
Measured: day 0
Per-operative X-ray exposure dose (mGy.cm2)
Measured: day 0
Per-operative Hardware or software malfunction
Per-operative Hardware or software malfunction (Yes/No)
Measured: day 0
Per-operative Intraoperative complication
Measured: day 0
Per-operative Complication
Per-operative Complication (adverse events table)
Measured: day 0
Immediate post-operative Discharge time (days)
Measured: up to 12 months
Immediate post-operative Length of hospital stay (days)
Measured: up to 12 months
Immediate post-operative Adverse events
Immediate post-operative Adverse events (table)
Measured: up to 12 months
9-month follow-up Adverse events
9-month follow-up Adverse events (table)
Measured: at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start21 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pedicle Screw AccuracyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421752
- Sponsor's protocol ID
- PI2024_843_0119
- Acronym
- Robotec Amiens
- Status last verified
- Jan 2026
- First submitted
- 10 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery at Amiens Picardie University Hospital
- ClinicalTrials.gov ID
- NCT07421752
- Acronym / sponsor ID
- Robotec Amiens / PI2024_843_0119
- Conditions
- Pedicle Screw Accuracy, Robot, Navigation, Spine, Scoliosis
- Keywords
- Pedicle screw accuracy, robot, navigation, spine, scoliosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spinal surgery has evolved considerably over the years, and the introduction of advanced technologies has played a crucial role in improving clinical outcomes. The use of surgical robots, such as the eCential Robotic system, has emerged as an innovative solution for optimizing the precision and safety of procedures, particularly the placement of pedicle screws in the spine.
The eCential Robotics surgical robot offers several advantages for the placement of pedicle screws in the spine. Various studies have demonstrated a significant improvement in screw accuracy and stability, reducing revision surgery rates with surgical robots. The system enables advanced preoperative planning based on three-dimensional imaging, improving understanding of the patient's specific anatomy. This study will also provide a clinical basis for the CE marking process.
The objective of this prospective study is to collect data confirming safety, performance and clinical benefits of the eCential Robotics robot when used during spine and pelvic surgeries.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 5 years or older.
- Treated at CHU Amiens Picardie for spinal surgery requiring implantation of pedicle screws.
- Informed consent signed by patient or legal representative and child.
- Membership of a social security scheme.
- Negative pregnancy test for adolescent women of childbearing age
Key exclusion criteria (5 listed)
- Patient managed by a practitioner with no experience of the eCential Robotics robot.
- Patient requiring a technique without implantation of pedicle screws.
- Patients already suffering from deterministic radiation effects
- Pregnant, parturient or breast-feeding women.
- Patients under guardianship or curators, under safeguard of justice or deprived under public law.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eCential Robotics solutionThe robotic aid is adaptable to all cannulated pedicle screw implantations in spine surgery. The eCential Robotics solution consists of a unified platform combining 2D/3D imaging, navigation and robotics. The procedure consists of : * Setting up the patient reference on the patient's spinal processes * 2D then 3D imaging (low-dose technology, using a 5-axis motorized X-ray C-arm to optimize trajectory and increase reconstruction volume) * Intraoperative planning of implants based on the patient's image in the operating position * Navigation: automatic matching of patient and 3D imagery with factory pre-calibrated single-use instruments. Real-time visualization of the trajectory in the 3D image. * Robotic surgery: collaborative robot-surgeon handling. Automatic alignment of pedicle aiming instruments with workflow control from the sterile zone. * 3D imaging to control screw positioning | Procedure or surgery | – |
Primary outcome
Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale
Time frame: 12 months
Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale. perfect intra-pedicular localization without any cortical breach (Grade A) * < 2 mm pedicle breach (Grade B) * < 4 mm pedicle breach (Grade C) * < 6 mm pedicle breach (Grade D) * ≥ 6 mm pedicle breach (Grade E) Screws graded A and B are clinically acceptable, screws graded C, D, E have a significant deviation from the intended trajectory.
10 secondary outcomes
Per-operative Blood loss (ml)
Time frame: day 0
Per-operative Operative time (min)
Time frame: day 0
Per-operative X-ray exposure dose (mGy.cm2)
Time frame: day 0
Per-operative Hardware or software malfunction
Time frame: day 0
Per-operative Intraoperative complication
Time frame: day 0
Per-operative Complication
Time frame: day 0
Immediate post-operative Discharge time (days)
Time frame: up to 12 months
Immediate post-operative Length of hospital stay (days)
Time frame: up to 12 months
Immediate post-operative Adverse events
Time frame: up to 12 months
9-month follow-up Adverse events
Time frame: at 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCential Robotics solution in people with Pedicle Screw Accuracy and Robot, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François DEROUSSEN, MD (33+322087576, deroussen.francois@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.