Bone FracturesULD-TraumatoNCT04074733
Diagnostic Performance of the Ultra Low-Dose (ULD) Scanner vs. Diagnostic Performance With Standard X-rays in the Emergency Department Compared With Performance of the Standard Classical-dose Scanner for Trauma of the Dorsolumbar Spine, Pelvis and Extremities
An observational study of Bone Fractures, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
Trial summary
The conventional standard-dose scanner leads to a significantly greater X-ray exposure than the standard X-ray. Recently, technological innovations like the ULD ("Ultra Low Dose") scanner have been developed to reduce the dose of X-rays delivered to the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Fractures
- What is being tested?
- Patient undergoes a ULD scan, Patient undergoes a standard X-ray and Patient undergoes a classic-dose scan
- How many people
- 554 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Oct 2019to 12 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient presenting at the emergency department patient for trauma of the dorso-lumbar spine, pelvis, proximal femurs, and / or extremities requiring standard X-rays.
Who may be able to join
- Patient with a BMI <40 kg / m²
- Emergency department patient for trauma of the dorso-lumbar spine, pelvis, proximal femurs, and / or extremities requiring standard radiographs
- Patient with painful symptomatology causing suspicion of a broken bone
- Patient or family member / trusted person / family member who has given free and informed consent
- Patient or family member / trusted person / family member who has signed the consent form
- Patient beneficiary or affiliate of a health insurance plan
Who cannot join
- Patient participating in a category 1 study
- Patient in a period of exclusion determined by another study
- Patient on under juridical protection, under curatorship or under guardianship
- Patient for whom it is impossible to give informed information
- Pregnant, parturient or nursing patient
- Polytraumatised patient
- Patients in vital emergency requiring urgent scanner
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Menouer TALEB
Alès
Clinique du Parc
Castelnau-le-Lez, Hérault, 34170
Centre Hospitalier de Mont-de-Marsan
Mont-de-Marsan, New Aquitaine, 40024
Centre Hospitalier Universitaire
Nîmes, Gard, 30029
Clinique de l'Union
Saint-Jean, Haute-Garonne, 31240
About this study
The conventional standard-dose scanner leads to a significantly greater X-ray exposure than the standard X-ray. Recently, technological innovations like the ULD ("Ultra Low Dose") scanner have been developed to reduce the dose of X-rays delivered to the patient. The general purpose of this study is to validate the ULD scanner in case of emergency trauma of the dorsolumbar spine, pelvis and / or extremities.
Read the detailed description
The main purpose of this study is to compare the diagnostic performances of the ULD scanner with those of the standard X-ray when looking for fractures of the dorsolumbar region, the pelvis, proximal femur or the extremities, in an emergency situation in adults, once the diagnosis of fracture has been ascertained by the classical standard-dose scanner (gold standard). The statistical analyses will be performed with the help version 9.4 or subsequent versions of SAS software (SAS Institute, Cary, NC, USA) and/or version 3.5.1 or subsequent versions of R software (R Development Core Team (2018). R Foundation for Statistical Computing, Vienna, Austria).
The secondary objectives of this study are to:
- Compare the diagnostic performances of the two examination methods under study (ULD scan vs. standard X-ray) in the search for bone structure anomalies, damage to the soft tissues, damage to the joints and/or discopathies at the site(s) involved.
- Compare the diagnostic performances of the two examination methods under study) (ULD scan vs. standard X-ray) in the search for fractures of the site involved. C. Evaluate the diagnostic agreement between two readers (senior radiologist and junior radiologist) for each of the two examination methods under study (ULD scan vs. standard X-ray).
- Compare the radiologist's self-declared impression of each of the two examination methods under study (ULD scan vs. standard X-ray) in terms of subjective quality: overall image quality, diagnostic quality of the examination method and the level of confidence in the diagnosis made, overall and for each of the two readers (senior and junior).
- Compare the doses of X-rays administered for each of the two examination methods under study (ULD scan vs. standard X-ray).
- Compare the interpretation time for each examination method under study (ULD scan vs. standard X-ray), globally and for each of the two readers (senior and junior).
For the evaluation of the diagnostic performances (main objective and secondary objectives A et B), only the senior radiologist's interpretation will be considered.
- Conditions
- Bone Fractures
- Being tested
- Patient undergoes a ULD scan, Patient undergoes a standard X-ray, Patient undergoes a classic-dose scan
- Keywords
- ULD
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient undergoes a ULD scanDiagnostic test
The following doses will be applied:
6 mGy.cm for the extremities 50 mGy.cm for the dorsal spine 130 mGy.cm for the lumbar spine 130 mGy.cm for the pelvis
Patient undergoes a standard X-rayDiagnostic test
The following doses will be applied:
For the pelvis : front view and profile for the hip. For the dorsal spine : front and profile. For the lumbar spine : front and profile For the extremities : front and profile
Patient undergoes a classic-dose scanDiagnostic test
The following doses will be applied:
6 mGy.cm for the extremities 50 mGy.cm for the dorsal spine 130 mGy.cm for the lumbar spine 130 mGy.cm for the pelvis
| Study group | Role | What they receive |
|---|---|---|
| Patients with fractures | Not described Receives: Diagnostic Test: Patient undergoes a ULD scan; Diagnostic Test: Patient undergoes a standard X-ray; Diagnostic Test: Patient undergoes a classic-dose scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of at least one fracture in the dorsal spine evaluated with a classical, standard-dose scan (Gold standard)
YES/NO
Measured: Day 0
Presence of at least one fracture in the lumbar spine evaluated with a classical, standard-dose scan (Gold standard)
YES/NO
Measured: Day 0
Presence of at least one fracture of the pelvis and proximal femurs evaluated with a classical, standard-dose scan (Gold standard)
YES/NO
Measured: Day 0
Presence of at least one fracture of the hands / wrists evaluated with a classical, standard-dose scan (Gold standard)
YES/NO
Measured: Day 0
Presence of at least one fracture of the feet /ankles evaluated with a classical, standard-dose scan (Gold standard)
YES/NO
Measured: Day 0
Presence of at least one fracture in the dorsal spine evaluated with a ULD scan
YES/NO
Measured: Day 0
Presence of at least one fracture in the lumbar spine evaluated with a ULD scan
YES/NO
Measured: Day 0
Presence of at least one fracture in the pelvis and proximal femurs evaluated with a ULD scan
YES/NO
Measured: Day 0
Presence of at least one fracture of the hands / wrists evaluated with a ULD scan
YES/NO
Measured: Day 0
Presence of at least one fracture of the feet /ankles evaluated with a ULD scan
YES/NO
Measured: Day 0
Presence of at least one fracture of the dorsal spine evaluated with a standard X-ray
YES/NO
Measured: Day 0
Presence of at least one fracture of the lumbar spine evaluated with a standard X-ray
YES/NO
Measured: Day 0
Presence of at least one fracture of the pelvis and proximal femurs evaluated with a standard X-ray
YES/NO
Measured: Day 0
Presence of at least one fracture of the hands / wrists evaluated with a standard X-ray
YES/NO
Measured: Day 0
Presence of at least one fracture of the feet /ankles evaluated with a standard X-ray
YES/NO
Measured: Day 0
Secondary outcomes (19)
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
YES/NO
Measured: Day 0
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
YES/NO
Measured: Day 0
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
YES/NO
Measured: Day 0
Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
YES/NO
Measured: Day 0
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a ULD scan
YES/NO
Measured: Day 0
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a ULD scan
YES/NO
Measured: Day 0
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a ULD scan
YES/NO
Measured: Day 0
Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a ULD scan
YES/NO
Measured: Day 0
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a standard X-ray
YES/NO
Measured: Day 0
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a standard X-ray
YES/NO
Measured: Day 0
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a standard X-ray
YES/NO
Measured: Day 0
Presence of an abnormality of the intervertebral discs at the anatomic concerned site(s) evaluated with a standard X-ray
YES/NO
Measured: Day 0
Image quality of the ULD scanner and standard X-ray
By means of a 4-point Likert scale, both the senior and junior radiologists can give their subjective impression of the overall image quality of each of the two examination methods under study (ULD scan vs. standard X-ray) by saying how much they agree or disagree that the overall quality of the image is good enough to detect a fracture. On the Lickert scale, 1- Uninterpretable, 2- Interpretable in spite of a slight technical problem (centering, movement, constant), 3-Completely interpretable in spite of a slight technical problem. 4- No technical problem.
Measured: Day 0
Diagnostic quality of the ULD scanner and standard X-ray
Using a 5-point Lickert scale (in which 1= Inacceptable, 2 = Sub-optimal, 3 = Acceptable, 4 = Above average, 5- Excellent) both the senior and junior radiologists will give their subjective impression of the overall diagnostic quality of each of the two examination methods under study (ULD scan vs. standard X-ray).
Measured: Day 0
Confidence level of the ULD scanner and standard X-ray
Using a 5-point Lickert scale (1- Very poor, 2- Poor, 3- Fair, 4- Good, 5- Excellent) both the senior and junior radiologists will give their subjective impression of their overall level of confidence in the diagnosis made for each of the two examination methods under study (ULD scan vs. standard X-ray).
Measured: Day 0
Effective dose for each exam with the ULD scanner
No. of millisieverts (mSv)
Measured: Day 0
Effective dose for each exam with the standard X-ray
No. of millisieverts (mSv)
Measured: Day 0
Interpretation time for each exam with the ULD scanner
Measured in minutes
Measured: Day 0
Interpretation time for each exam with the standard X-ray
Measured in minutes
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start21 Oct 2019
- Primary completion12 Sep 2023
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone FracturesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed LARBI, Dr., Principal investigator, CHU de Nîmes (Nîmes University Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074733
- Sponsor's protocol ID
- PHRCi/2018/AL-01
- Other IDs
- 2019-A00472-55
- Acronym
- ULD-Traumato
- Status last verified
- Dec 2025
- First submitted
- 23 Aug 2019
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hamard A, Greffier J, Bastide S, Larbi A, Addala T, Sadate A, Beregi JP, Frandon J. Ultra-low-dose CT versus radiographs for minor spine and pelvis trauma: a Bayesian analysis of accuracy. Eur Radiol. 2021 Apr;31(4):2621-2633. doi: 10.1007/s00330-020-07304-8. Epub 2020 Oct 9.
PubMed 33034747
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of the Ultra Low-Dose (ULD) Scanner vs. Diagnostic Performance With Standard X-rays in the Emergency Department Compared With Performance of the Standard Classical-dose Scanner for Trauma of the Dorsolumbar Spine, Pelvis and Extremities
- ClinicalTrials.gov ID
- NCT04074733
- Acronym / sponsor ID
- ULD-Traumato / PHRCi/2018/AL-01
- Conditions
- Bone Fractures
- Keywords
- ULD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 30 Aug 2019 (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.
The conventional standard-dose scanner leads to a significantly greater X-ray exposure than the standard X-ray. Recently, technological innovations like the ULD ("Ultra Low Dose") scanner have been developed to reduce the dose of X-rays delivered to the patient. The general purpose of this study is to validate the ULD scanner in case of emergency trauma of the dorsolumbar spine, pelvis and / or extremities.
Detailed description
The main purpose of this study is to compare the diagnostic performances of the ULD scanner with those of the standard X-ray when looking for fractures of the dorsolumbar region, the pelvis, proximal femur or the extremities, in an emergency situation in adults, once the diagnosis of fracture has been ascertained by the classical standard-dose scanner (gold standard). The statistical analyses will be performed with the help version 9.4 or subsequent versions of SAS software (SAS Institute, Cary, NC, USA) and/or version 3.5.1 or subsequent versions of R software (R Development Core Team (2018). R Foundation for Statistical Computing, Vienna, Austria).
The secondary objectives of this study are to:
- Compare the diagnostic performances of the two examination methods under study (ULD scan vs. standard X-ray) in the search for bone structure anomalies, damage to the soft tissues, damage to the joints and/or discopathies at the site(s) involved.
- Compare the diagnostic performances of the two examination methods under study) (ULD scan vs. standard X-ray) in the search for fractures of the site involved. C. Evaluate the diagnostic agreement between two readers (senior radiologist and junior radiologist) for each of the two examination methods under study (ULD scan vs. standard X-ray).
- Compare the radiologist's self-declared impression of each of the two examination methods under study (ULD scan vs. standard X-ray) in terms of subjective quality: overall image quality, diagnostic quality of the examination method and the level of confidence in the diagnosis made, overall and for each of the two readers (senior and junior).
- Compare the doses of X-rays administered for each of the two examination methods under study (ULD scan vs. standard X-ray).
- Compare the interpretation time for each examination method under study (ULD scan vs. standard X-ray), globally and for each of the two readers (senior and junior).
For the evaluation of the diagnostic performances (main objective and secondary objectives A et B), only the senior radiologist's interpretation will be considered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with fractures | – | Diagnostic Test: Patient undergoes a ULD scan, Diagnostic Test: Patient undergoes a standard X-ray, Diagnostic Test: Patient undergoes a classic-dose scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient presenting at the emergency department patient for trauma of the dorso-lumbar spine, pelvis, proximal femurs, and / or extremities requiring standard X-rays.
Key inclusion criteria (6 listed)
- Patient with a BMI <40 kg / m²
- Emergency department patient for trauma of the dorso-lumbar spine, pelvis, proximal femurs, and / or extremities requiring standard radiographs
- Patient with painful symptomatology causing suspicion of a broken bone
- Patient or family member / trusted person / family member who has given free and informed consent
- Patient or family member / trusted person / family member who has signed the consent form
Key exclusion criteria (7 listed)
- Patient participating in a category 1 study
- Patient in a period of exclusion determined by another study
- Patient on under juridical protection, under curatorship or under guardianship
- Patient for whom it is impossible to give informed information
- Pregnant, parturient or nursing patient
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 |
|---|---|---|
| Patient undergoes a ULD scanThe following doses will be applied: 6 mGy.cm for the extremities 50 mGy.cm for the dorsal spine 130 mGy.cm for the lumbar spine 130 mGy.cm for the pelvis | Diagnostic test | Patients with fractures |
| Patient undergoes a standard X-rayThe following doses will be applied: For the pelvis : front view and profile for the hip. For the dorsal spine : front and profile. For the lumbar spine : front and profile For the extremities : front and profile | Diagnostic test | Patients with fractures |
| Patient undergoes a classic-dose scanThe following doses will be applied: 6 mGy.cm for the extremities 50 mGy.cm for the dorsal spine 130 mGy.cm for the lumbar spine 130 mGy.cm for the pelvis | Diagnostic test | Patients with fractures |
Primary outcome
Presence of at least one fracture in the dorsal spine evaluated with a classical, standard-dose scan (Gold standard)
Time frame: Day 0
YES/NO
Presence of at least one fracture in the lumbar spine evaluated with a classical, standard-dose scan (Gold standard)
Time frame: Day 0
YES/NO
Presence of at least one fracture of the pelvis and proximal femurs evaluated with a classical, standard-dose scan (Gold standard)
Time frame: Day 0
YES/NO
Presence of at least one fracture of the hands / wrists evaluated with a classical, standard-dose scan (Gold standard)
Time frame: Day 0
YES/NO
Presence of at least one fracture of the feet /ankles evaluated with a classical, standard-dose scan (Gold standard)
Time frame: Day 0
YES/NO
Presence of at least one fracture in the dorsal spine evaluated with a ULD scan
Time frame: Day 0
YES/NO
Presence of at least one fracture in the lumbar spine evaluated with a ULD scan
Time frame: Day 0
YES/NO
Presence of at least one fracture in the pelvis and proximal femurs evaluated with a ULD scan
Time frame: Day 0
YES/NO
Presence of at least one fracture of the hands / wrists evaluated with a ULD scan
Time frame: Day 0
YES/NO
Presence of at least one fracture of the feet /ankles evaluated with a ULD scan
Time frame: Day 0
YES/NO
Presence of at least one fracture of the dorsal spine evaluated with a standard X-ray
Time frame: Day 0
YES/NO
Presence of at least one fracture of the lumbar spine evaluated with a standard X-ray
Time frame: Day 0
YES/NO
Presence of at least one fracture of the pelvis and proximal femurs evaluated with a standard X-ray
Time frame: Day 0
YES/NO
Presence of at least one fracture of the hands / wrists evaluated with a standard X-ray
Time frame: Day 0
YES/NO
Presence of at least one fracture of the feet /ankles evaluated with a standard X-ray
Time frame: Day 0
YES/NO
19 secondary outcomes
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
Time frame: Day 0
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
Time frame: Day 0
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
Time frame: Day 0
Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
Time frame: Day 0
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a ULD scan
Time frame: Day 0
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a ULD scan
Time frame: Day 0
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a ULD scan
Time frame: Day 0
Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a ULD scan
Time frame: Day 0
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a standard X-ray
Time frame: Day 0
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a standard X-ray
Time frame: Day 0
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a standard X-ray
Time frame: Day 0
Presence of an abnormality of the intervertebral discs at the anatomic concerned site(s) evaluated with a standard X-ray
Time frame: Day 0
Image quality of the ULD scanner and standard X-ray
Time frame: Day 0
Diagnostic quality of the ULD scanner and standard X-ray
Time frame: Day 0
Confidence level of the ULD scanner and standard X-ray
Time frame: Day 0
Effective dose for each exam with the ULD scanner
Time frame: Day 0
Effective dose for each exam with the standard X-ray
Time frame: Day 0
Interpretation time for each exam with the ULD scanner
Time frame: Day 0
Interpretation time for each exam with the standard X-ray
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 33034747Hamard A, Greffier J, Bastide S, Larbi A, Addala T, Sadate A, Beregi JP, Frandon J. Ultra-low-dose CT versus radiographs for minor spine and pelvis trauma: a Bayesian analysis of accuracy. Eur Radiol. 2021 Apr;31(4):2621-2633. doi: 10.1007/s00330-020-07304-8. Epub 2020 Oct 9.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ahmed LARBI, Dr. principal investigator
CHU de Nîmes (Nîmes University Hospital)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Fractures, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of at least one fracture in the dorsal spine evaluated with a classical, standard-dose scan (Gold standard) (time frame: Day 0). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04074733, which also lists 1 linked publication.
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 10 Dec 2025.