CLAP : Compare the Quality of 3D Modeling of the Wrist Based on the Cone Beam to the Gold Standard
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: wrist Cone-beam CT, wrist CT scan.
- Who it may be relevant to
- Registry conditions: Wrist Injuries, Ligament Injury. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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
- Other wrist Cone-beam CT
Perfoming a wrist Cone-beam scan 7 days after study inclusion - Other wrist CT scan
Perfoming a wrist CT scan 22 days after study inclusion
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07632521 · 2025/1018