Reverse Shoulder ProsthesisSEGMENTATIONNCT05376813
An Algorithm Creation by Automated Segmentation by MRI for Bone and Muscles of Shoulder
A study testing CT-Scan and MRI in people with Reverse Shoulder Prosthesis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The primary objective of the study is to develop an algorithm of automated segmentation of shoulder by MRI examinations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reverse Shoulder Prosthesis
- What is being tested?
- CT-Scan and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2023to 28 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer > 18 years, presenting any symptom nor history of shoulder pathology;
- Affiliated to social security scheme.
Who cannot join
- Symptoms or history of shoulder pathologies;
- Claustrophobia;
- Pregnant woman;
- Patient covered by AME system;
- Contre-indication to perform MRI examination (implant, less 6-months stent implantation, recent surgery, renal insufficiency, pace maker implantation, cardiac defibrillator, cardiovascular catheter, neurostimulation, implantable electronic pompe for automatic injection of medications).
About this study
Official title: Elaboration of an Algorithm of Automated Segmentation by Magnetic Resonance Imaging for Bone and Muscles of Shoulder
The primary objective of the study is to develop an algorithm of automated segmentation of shoulder by MRI examinations.
Read the detailed description
This is a national monocentric study which will be conducted in Ambroise Paré hospital of APHP, in orthopaedics department (for enrollment) and radiological department (for CT-scan and MRI examinations) respectively.
Manual segmentations of 5 muscles and 2 bones of shoulder by MRI with automated segmentation of shoulders corresponding to CT-scan imagings.
3D imagings of each shoulder by manual segmentations from MRI and automated segmentation from computed tomography will provide to build a network.
The perspective of the elaborated algorithm should lead to an automated 3D-reconstruction of patients' shoulder as a routine care in surgery.
- Conditions
- Reverse Shoulder Prosthesis
- Being tested
- CT-Scan and MRI
- Keywords
- Reverse Shoulder Prosthesis, Algorithm, Automatic segmentation, Magnetic resonance imaging, Computed tomography, 3D imaging, Manual segmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-Scan and MRIProcedure or surgery
CT-Scan and MRI examination for shoulder will be performed on healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | All participants are healthy volunteers Receives: Procedure: CT-Scan and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm developement
The developement for automatic segmentation algorithm: uses method with a convolutional neural networks (convolutional neural network - CNN).
Measured: through study completion, an average of 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start31 Aug 2023
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Why it stopped: NO ENROULEMENT
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse Shoulder ProsthesisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Model description
- No comparative, no control study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-David Werthel, MD, Principal investigator, Orthopaedics, Ambroise Paré hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376813
- Sponsor's protocol ID
- APHP220324
- Other IDs
- 2022-A00301-42
- Acronym
- SEGMENTATION
- Status last verified
- Jun 2024
- First submitted
- 9 May 2022
- Last updated
- 19 Mar 2025
- 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaboration of an Algorithm of Automated Segmentation by Magnetic Resonance Imaging for Bone and Muscles of Shoulder
- ClinicalTrials.gov ID
- NCT05376813
- Acronym / sponsor ID
- SEGMENTATION / APHP220324
- Conditions
- Reverse Shoulder Prosthesis
- Keywords
- Reverse Shoulder Prosthesis, Algorithm, Automatic segmentation, Magnetic resonance imaging, Computed tomography, 3D imaging, Manual segmentation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NO ENROULEMENT
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 17 May 2022 (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.
The primary objective of the study is to develop an algorithm of automated segmentation of shoulder by MRI examinations.
Detailed description
This is a national monocentric study which will be conducted in Ambroise Paré hospital of APHP, in orthopaedics department (for enrollment) and radiological department (for CT-scan and MRI examinations) respectively.
Manual segmentations of 5 muscles and 2 bones of shoulder by MRI with automated segmentation of shoulders corresponding to CT-scan imagings.
3D imagings of each shoulder by manual segmentations from MRI and automated segmentation from computed tomography will provide to build a network.
The perspective of the elaborated algorithm should lead to an automated 3D-reconstruction of patients' shoulder as a routine care in surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- No comparative, no control study
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: CT-Scan and MRIAll participants are healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteer > 18 years, presenting any symptom nor history of shoulder pathology;
- Affiliated to social security scheme.
Key exclusion criteria (5 listed)
- Symptoms or history of shoulder pathologies;
- Claustrophobia;
- Pregnant woman;
- Patient covered by AME system;
- Contre-indication to perform MRI examination (implant, less 6-months stent implantation, recent surgery, renal insufficiency, pace maker implantation, cardiac defibrillator, cardiovascular catheter, neurostimulation, implantable electronic pompe for automatic injection of medications).
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 |
|---|---|---|
| CT-Scan and MRICT-Scan and MRI examination for shoulder will be performed on healthy volunteers. | Procedure or surgery | Experimental arm |
Primary outcome
Algorithm developement
Time frame: through study completion, an average of 8 month
The developement for automatic segmentation algorithm: uses method with a convolutional neural networks (convolutional neural network - CNN).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Enrolling by invitationObservational study
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Shoulder Arthroplasty, Shoulder Joint Disease
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. This study is not recruiting at the moment.
Jean-David Werthel, MD principal investigator
Orthopaedics, Ambroise Paré hospital, APHP
Questions about this trial
What is this clinical trial studying?
A study testing CT-Scan and MRI in people with Reverse Shoulder Prosthesis, run by Assistance Publique - Hôpitaux de Paris.
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 2 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: withdrawn, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algorithm developement (time frame: through study completion, an average of 8 month). 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 Mar 2025.