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

CLAP: Single Center Prospective Study to Compare the Quality of 3D Modeling of the Wrist Based on the Cone Beam to the Gold Standard of CT SCAN in 6 Healthy Volunteers.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07632521
Acronym
CLAP
Enrollment
6
Registered
2026-06-08
Start date
2026-06-01
Completion date
2026-10-30
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ligament Injury, Wrist Injuries

Keywords

CT scan, cone-beam scan

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.

Interventions

OTHERwrist Cone-beam CT

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

OTHERwrist CT scan

Perfoming a wrist CT scan 22 days after study inclusion

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
To Estimate the mean bias (mm) and 95% confidence intervals between cone-beam CT and the gold standard (CT)22 days after inclusionTo compare the quality of 3D hand modeling based on cone-beam CT with the gold standard of computed tomography.

Contacts

CONTACTLOISEL François, MD
floisel@chu-besancon.fr+333.81.21.89.88
CONTACTManon BIEGUN, MD
mbiegun@chu-besancon.fr+333.81.21.89.88

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026