NCT05376813

Brief Summary

The primary objective of the study is to develop an algorithm of automated segmentation of shoulder by MRI examinations.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2024

Completed
Last Updated

March 19, 2025

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

May 9, 2022

Last Update Submit

March 17, 2025

Conditions

Reverse Shoulder Prosthesis

Keywords

Reverse Shoulder ProsthesisAlgorithmAutomatic segmentationMagnetic resonance imagingComputed tomography3D imagingManual segmentation

Outcome Measures

Primary Outcomes (1)

  • Algorithm developement

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

    through study completion, an average of 8 month

Study Arms (1)

Experimental arm

EXPERIMENTAL

All participants are healthy volunteers

Procedure: CT-Scan and MRI

Interventions

CT-Scan and MRIPROCEDURE

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

Experimental arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jean-David Werthel, MD

    Orthopaedics, Ambroise Paré hospital, APHP

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: No comparative, no control study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 17, 2022

Study Start

August 31, 2023

Primary Completion

April 28, 2024

Study Completion

April 28, 2024

Last Updated

March 19, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share