CLAP : Compare the Quality of 3D Modeling of the Wrist Based on the Cone Beam to the Gold Standard

NCT07632521 | Not Yet Recruiting

• 1 other identifier: 2025/1018
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recent advances in personalized 3D modeling make it possible to consider personalized hand modeling based on cone-beam CT. The goal is to develop a personalized 3D modeling tool for use in routine clinical practice that reduces both the radiation dose to which patients are currently exposed during CT scans and the time required to process CT data (segmentation). the main, objective of the study is to compare the quality of 3D hand modeling based on cone-beam CT with the gold standard of computed tomography. This prospective, single-center, interventional study will include 6 healthy volunteers.

Conditions

Ligament Injury; Wrist Injuries

Keywords

CT scan; cone-beam scan

Outcome Measures

Primary Outcomes (1)

• To Estimate the mean bias (mm) and 95% confidence intervals between cone-beam CT and the gold standard (CT)

  To compare the quality of 3D hand modeling based on cone-beam CT with the gold standard of computed tomography.

  22 days after inclusion

Study Arms (1)

wrist cone-beam CT and Ct scan

EXPERIMENTAL

All subject will perform a wrist cone-beam CT 7 days after inclusion and a wrist CT scan 22 days after inclusion

Other: wrist Cone-beam CT; Other: wrist CT scan

Interventions

wrist Cone-beam CT OTHER

Perfoming a wrist Cone-beam scan 7 days after study inclusion

wrist cone-beam CT and Ct scan

wrist CT scan OTHER

Perfoming a wrist CT scan 22 days after study inclusion

wrist cone-beam CT and Ct scan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• no clinical symptoms suggestive of a wrist ligament injury (e.g., pain, instability)
• no contraindications to undergoing a CBCT scan (e.g., pregnancy, history of hypersensitivity to radiation).
• Enrolled in or eligible for a French social security plan.
• Signing of an informed consent form indicating that the subject understands the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and restrictions inherent to this study

You may not qualify if:

• Pregnant women and breastfeeding mothers
• Persons deprived of their liberty by a judicial or administrative decision; persons undergoing involuntary psychiatric treatment; persons admitted to a health or social care facility for purposes other than research
• Adults subject to a legal protection measure (judicial protection, guardianship, or conservatorship) or who are unable to give consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Wrist Injuries

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Central Study Contacts

LOISEL François, MD

CONTACT

+333.81.21.89.88; floisel@chu-besancon.fr

Manon BIEGUN, MD

CONTACT

+333.81.21.89.88; mbiegun@chu-besancon.fr

Study Design

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

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06