NCT04895891

Brief Summary

This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

October 6, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5.2 years

First QC Date

May 17, 2021

Last Update Submit

September 5, 2024

Conditions

Hand Injuries

Outcome Measures

Primary Outcomes (2)

  • Data obtained through EOS imaging

    Precision and correlation of the 3D modelization of hand is compared between the two imaging methods

    Day 60

  • Data obtained through standard CT

    Precision and correlation of the 3D modelization of hand is compared between the two imaging methods

    Day 60

Study Arms (1)

EOS imaging

EXPERIMENTAL

For each patient, EOS images are compared with computed tomography \[CT\] images

Device: EOS hand imaging

Interventions

EOS hand imagingDEVICE

For each patient, EOS images are compared with CT images

EOS imaging

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, France

RECRUITING

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

François Loisel, MD

CONTACT

0033381667540floisel@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

October 6, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)