Hand InjuriesM3DMENCT04895891
3D Personalized Modelization of the Hand Using EOS Imaging System
A study testing EOS hand imaging in people with Hand Injuries, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries
- What is being tested?
- EOS hand imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2020to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with hand/wrist CT required
- Informed consent form signed
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon
François Loisel, MD
François Loisel, MS
About this study
This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography
- Conditions
- Hand Injuries
- Being tested
- EOS hand imaging
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS hand imagingDevice
For each patient, EOS images are compared with CT images
| Study group | Role | What they receive |
|---|---|---|
| EOS imaging | Experimental | For each patient, EOS images are compared with computed tomography [CT] images Receives: Device: EOS hand imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data obtained through EOS imaging
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
Measured: Day 60
Data obtained through standard CT
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start6 Oct 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895891
- Sponsor's protocol ID
- P/2019/444
- Acronym
- M3DME
- Status last verified
- Sep 2024
- First submitted
- 17 May 2021
- Last updated
- 19 Sep 2024
- 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 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Personalized Modelization of the Hand Using EOS Imaging System
- ClinicalTrials.gov ID
- NCT04895891
- Acronym / sponsor ID
- M3DME / P/2019/444
- Conditions
- Hand Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 May 2021 (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.
This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EOS imaging | Experimental | Device: EOS hand imagingFor each patient, EOS images are compared with computed tomography [CT] images |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with hand/wrist CT required
- Informed consent form signed
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EOS hand imagingFor each patient, EOS images are compared with CT images | Device | EOS imaging |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOS hand imaging in people with Hand Injuries, run by Centre Hospitalier Universitaire de Besancon 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Loisel, MD (0033381667540, floisel@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data obtained through EOS imaging (time frame: Day 60). The study lists 2 primary outcomes in all. 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 Sep 2024.