3D Personalized Modelization of the Hand Using EOS Imaging System (M3DME)

May 19, 2021 updated by: Centre Hospitalier Universitaire de Besancon
This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • CHU de Besancon
        • Contact:
          • François LOISEL, MD
        • Principal Investigator:
          • François Loisel, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with hand/wrist CT required
  • Informed consent form signed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EOS imaging
For each patient, EOS images are compared with computed tomography [CT] images
Device: EOS hand imaging
For each patient, EOS images are compared with CT images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data obtained through EOS imaging
Time Frame: Day 60
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
Day 60
Data obtained through standard CT
Time Frame: Day 60
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2019/444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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