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NCT Number: NCT07632521

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

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.

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Key information

Conditions

Wrist Injuries Arm Injuries Ligament Injury Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wrist Cone-beam CT

Other

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

wrist CT scan

Other

Perfoming a wrist CT scan 22 days after study inclusion

Primary outcomes

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

    Time frame: 22 days after inclusion

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

Study contacts

Contact information is provided by the study sponsor or research team.

LOISEL François, MD

CONTACT

[email protected]

+333.81.21.89.88

Manon BIEGUN, MD

CONTACT

[email protected]

+333.81.21.89.88

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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.

Acronym: CLAP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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