Wrist InjuriesCLAPNCT07632521
CLAP : Compare the Quality of 3D Modeling of the Wrist Based on the Cone Beam to the Gold Standard
A study testing wrist Cone-beam CT and wrist CT scan in people with Wrist Injuries and Ligament Injury, run by Centre Hospitalier Universitaire de Besancon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrist Injuries, Ligament Injury
- What is being tested?
- wrist Cone-beam CT and wrist CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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
- Wrist Injuries, Ligament Injury
- Being tested
- wrist Cone-beam CT, wrist CT scan
- Keywords
- CT scan, cone-beam scan
- Medical subject headings
- Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wrist Cone-beam CTOther
Perfoming a wrist Cone-beam scan 7 days after study inclusion
wrist CT scanOther
Perfoming a wrist CT scan 22 days after study inclusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: wrist Cone-beam CT; Other: wrist CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist InjuriesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632521
- Sponsor's protocol ID
- 2025/1018
- Acronym
- CLAP
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07632521
- Acronym / sponsor ID
- CLAP / 2025/1018
- Conditions
- Wrist Injuries, Ligament Injury
- Keywords
- CT scan, cone-beam scan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wrist cone-beam CT and Ct scan | Experimental | Other: wrist Cone-beam CT, Other: wrist CT scanAll subject will perform a wrist cone-beam CT 7 days after inclusion and a wrist CT scan 22 days after inclusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wrist Cone-beam CTPerfoming a wrist Cone-beam scan 7 days after study inclusion | Other | wrist cone-beam CT and Ct scan |
| wrist CT scanPerfoming a wrist CT scan 22 days after study inclusion | Other | wrist cone-beam CT and Ct scan |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing wrist Cone-beam CT and wrist CT scan in people with Wrist Injuries and Ligament Injury, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LOISEL François, MD (+333.81.21.89.88, floisel@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.