FractureNan-05NCT07900412
Evaluation of the Diagnostic Potential of Nanox.ARC Tomosynthesis System for Different Diseases
A study testing Nanox.ARC Digital Tomosynthesis System in people with Fracture and Erosion, run by Nano-X Imaging at 1 site in Israel.
Trial summary
This is a prospective, single-arm, clinical study evaluating the diagnostic performance of the Nanox.ARC Digital Tomosynthesis (DTS) system in adult patients with suspected or confirmed musculoskeletal (MSK) pathologies presenting to the Emergency Department (ED) or orthopedic outpatient clinic at Meir Medical Center… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- What is being tested?
- Nanox.ARC Digital Tomosynthesis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Oct 2026to 1 Aug 2027
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 years or older.
- Ability and willingness to read, understand, and sign the Informed Consent Form (ICF).
- Clinical status: has undergone a conventional radiograph with or without advanced imaging (CT/MRI) within the past 7 days for a suspected or confirmed MSK pathology; OR is referred to undergo advanced imaging (CT/MRI) or an additional radiograph within the same 7-day timeframe, in the presence of an available radiograph.
- Negative pregnancy test (for women under the age of 50).
Who cannot join
- Cases in which a delay caused by participation in the study could negatively impact the patient's clinical condition or pose a risk to their health or life.
- Pregnant or breastfeeding women.
- Body weight exceeding 150 kg.
- Inability to cooperate with the study procedures or to maintain the required position during the DTS scan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center5
Kfar Saba
Professor Nissim Ohana, Professor, 972-9-7471140, ohanan@clalit.org.il
About this study
This is a prospective, single-arm, clinical study evaluating the diagnostic performance of the Nanox.ARC Digital Tomosynthesis (DTS) system in adult patients with suspected or confirmed musculoskeletal (MSK) pathologies presenting to the Emergency Department (ED) or orthopedic outpatient clinic at Meir Medical Center, Israel. The study aims to assess whether DTS provides additional diagnostic information beyond conventional radiography and whether it can reduce the need for advanced imaging (CT/MRI) in MSK patients.
Read the detailed description
Imaging plays a crucial role in the diagnosis and management of MSK diseases. While conventional radiography is the standard first-line modality, it is limited by superimposition of anatomical structures. Digital Tomosynthesis (DTS) offers high-resolution limited-angle tomography at radiation doses comparable to conventional 2D radiography, with the potential to provide additional clinical information.
The Nanox.ARC is an FDA-cleared and CE-marked stationary DTS system intended for the imaging of anatomical regions of the human body in adult individuals in recumbent positions as an adjunct to conventional radiography. This study will evaluate its performance in MSK imaging in a real-world clinical setting.
Patients with suspected or confirmed MSK pathology who have undergone plain radiography and are referred for or have undergone advanced imaging (CT/MRI) will be enrolled. Each patient will additionally undergo a DTS scan with the Nanox.ARC system.
The study aims to determine:
- Whether DTS provides additional clinically relevant information compared to conventional radiography.
- Whether DTS could reduce the need for CT/MRI in MSK patients, thereby reducing radiation exposure and healthcare costs.
- Being tested
- Nanox.ARC Digital Tomosynthesis System
- Keywords
- MSK, Tomosynthesis, DTS
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanox.ARC Digital Tomosynthesis SystemDevice
Also called DTS; Digital Tomosynthesis; Nanox.ARC
A single DTS scan of the relevant MSK anatomical region performed using the Nanox.ARC stationary digital tomosynthesis system. The scan consists of multiple sequential low-dose X-ray projections acquired from different angles and reconstructed into tomographic sections. The radiation dose for an extremity scan is approximately 0.003 mSv, significantly lower than a CT scan.
| Study group | Role | What they receive |
|---|---|---|
| MSK Patients - DTS with Nanox.ARC | Experimental | Adult patients with suspected or confirmed MSK pathology presenting to the ED or orthopedic clinic who have undergone conventional radiography and are referred to imaging for follow up. All enrolled subjects additionally undergo a single DTS scan with the Nanox.ARC system within 7 days of the initial radiograph. Receives: Device: Nanox.ARC Digital Tomosynthesis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Cases in Which DTS Provided Additional Diagnostic Information Compared to Conventional Radiography
Proportion of cases in which Nanox.ARC DTS provided additional clinically relevant information compared to conventional 2D radiography, including better depiction and localization of lesions and higher diagnostic confidence, when evaluating adult patients with known or suspected MSK abnormalities.
Measured: Within 7 days of initial radiograph (single study visit)
Secondary outcomes (1)
Rate of Cases in Which DTS Was Sufficient for Clinical Management Without Requiring Advanced Imaging
Proportion of cases in which Nanox.ARC DTS, in addition to conventional radiography, was sufficient for patient clinical management without requiring CT/MRI or other advanced imaging modalities.
Measured: Within 7 days of initial radiograph (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nano-X Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meir Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900412
- Sponsor's protocol ID
- Nan-05
- Other IDs
- MOH_2026_05_31_016854
- Acronym
- Nan-05
- Status last verified
- Jun 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Potential of Nanox.ARC Tomosynthesis System for Different Diseases
- ClinicalTrials.gov ID
- NCT07900412
- Acronym / sponsor ID
- Nan-05 / Nan-05
- Keywords
- MSK, Tomosynthesis, DTS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nano-X ImagingIndustry (pharma, biotech, devices)
- Collaborators
- Meir Medical Center
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 28 Oct 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.
This is a prospective, single-arm, clinical study evaluating the diagnostic performance of the Nanox.ARC Digital Tomosynthesis (DTS) system in adult patients with suspected or confirmed musculoskeletal (MSK) pathologies presenting to the Emergency Department (ED) or orthopedic outpatient clinic at Meir Medical Center, Israel. The study aims to assess whether DTS provides additional diagnostic information beyond conventional radiography and whether it can reduce the need for advanced imaging (CT/MRI) in MSK patients.
Detailed description
Imaging plays a crucial role in the diagnosis and management of MSK diseases. While conventional radiography is the standard first-line modality, it is limited by superimposition of anatomical structures. Digital Tomosynthesis (DTS) offers high-resolution limited-angle tomography at radiation doses comparable to conventional 2D radiography, with the potential to provide additional clinical information.
The Nanox.ARC is an FDA-cleared and CE-marked stationary DTS system intended for the imaging of anatomical regions of the human body in adult individuals in recumbent positions as an adjunct to conventional radiography. This study will evaluate its performance in MSK imaging in a real-world clinical setting.
Patients with suspected or confirmed MSK pathology who have undergone plain radiography and are referred for or have undergone advanced imaging (CT/MRI) will be enrolled. Each patient will additionally undergo a DTS scan with the Nanox.ARC system.
The study aims to determine:
- Whether DTS provides additional clinically relevant information compared to conventional radiography.
- Whether DTS could reduce the need for CT/MRI in MSK patients, thereby reducing radiation exposure and healthcare costs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSK Patients - DTS with Nanox.ARC | Experimental | Device: Nanox.ARC Digital Tomosynthesis SystemAdult patients with suspected or confirmed MSK pathology presenting to the ED or orthopedic clinic who have undergone conventional radiography and are referred to imaging for follow up. All enrolled subjects additionally undergo a single DTS scan with the Nanox.ARC system within 7 days of the initial radiograph. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients aged 18 years or older.
- Ability and willingness to read, understand, and sign the Informed Consent Form (ICF).
- Clinical status: has undergone a conventional radiograph with or without advanced imaging (CT/MRI) within the past 7 days for a suspected or confirmed MSK pathology; OR is referred to undergo advanced imaging (CT/MRI) or an additional radiograph within the same 7-day timeframe, in the presence of an available radiograph.
- Negative pregnancy test (for women under the age of 50).
Key exclusion criteria (4 listed)
- Cases in which a delay caused by participation in the study could negatively impact the patient's clinical condition or pose a risk to their health or life.
- Pregnant or breastfeeding women.
- Body weight exceeding 150 kg.
- Inability to cooperate with the study procedures or to maintain the required position during the DTS scan.
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 |
|---|---|---|
| Nanox.ARC Digital Tomosynthesis SystemAlso: DTS; Digital Tomosynthesis; Nanox.ARCA single DTS scan of the relevant MSK anatomical region performed using the Nanox.ARC stationary digital tomosynthesis system. The scan consists of multiple sequential low-dose X-ray projections acquired from different angles and reconstructed into tomographic sections. The radiation dose for an extremity scan is approximately 0.003 mSv, significantly lower than a CT scan. | Device | MSK Patients - DTS with Nanox.ARC |
Primary outcome
Rate of Cases in Which DTS Provided Additional Diagnostic Information Compared to Conventional Radiography
Time frame: Within 7 days of initial radiograph (single study visit)
Proportion of cases in which Nanox.ARC DTS provided additional clinically relevant information compared to conventional 2D radiography, including better depiction and localization of lesions and higher diagnostic confidence, when evaluating adult patients with known or suspected MSK abnormalities.
1 secondary outcome
Rate of Cases in Which DTS Was Sufficient for Clinical Management Without Requiring Advanced Imaging
Time frame: Within 7 days of initial radiograph (single study visit)
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 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Fracture
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanox.ARC Digital Tomosynthesis System in people with Fracture and Erosion, run by Nano-X Imaging at 1 site in Israel.
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 4 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Cases in Which DTS Provided Additional Diagnostic Information Compared to Conventional Radiography (time frame: Within 7 days of initial radiograph (single study visit)). 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 28 Oct 2026.