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WithdrawnNCT05376813SEGMENTATIONUpdated Mar 19, 2025

An Algorithm Creation by Automated Segmentation by MRI for Bone and Muscles of Shoulder

An interventional study of CT-Scan and MRI in Reverse Shoulder Prosthesis, sponsored by Assistance Publique - Hôpitaux de Paris. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

Why this study was withdrawn
NO ENROULEMENT
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Reverse Shoulder Prosthesis

Keywords

  • Reverse Shoulder Prosthesis
  • Algorithm
  • Automatic segmentation
  • Magnetic resonance imaging
  • Computed tomography
  • 3D imaging
  • Manual segmentation
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteer > 18 years, presenting any symptom nor history of shoulder pathology;
  • Affiliated to social security scheme.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Experimental arm

    All participants are healthy volunteers

    Procedure: CT-Scan and MRI

Interventions

  • ProcedureCT-Scan and MRI

    CT-Scan and MRI examination for shoulder will be performed on healthy volunteers.

06

What researchers measure

Primary outcomes

  1. Algorithm developement

    The developement for automatic segmentation algorithm: uses method with a convolutional neural networks (convolutional neural network - CNN).

    Time frame: through study completion, an average of 8 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05376813
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
May 17, 2022
Start date
Aug 31, 2023
Primary completion
Apr 28, 2024
Completion
Apr 28, 2024
Last update
Mar 19, 2025

Study contacts

Jean-David Werthel, MD
principal investigator · Orthopaedics, Ambroise Paré hospital, APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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