Lung NoduleVERITASNCT04250194
Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
A study testing CT-Guided Biopsy and Navigation bronchoscopy in people with Lung Nodule, run by Vanderbilt-Ingram Cancer Center at 7 sites in United States.
Trial summary
This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Nodule
- What is being tested?
- CT-Guided Biopsy and Navigation bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 May 2020to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy:
- Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 100%, using a validated clinical prediction model, which is either:
- The Brock model14 if no PET scan data are available, or
- The Herder model15 if PET-CT data are available.
- Size between 10 and 30 mm (long diameter).
- Location peripheral, here defined as occupying the middle or outer third lung zones.
- Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.
Who cannot join
- Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.
- Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Rush University Medical Center
Chicago, Illinois, 60612
Kootenai Health
Coeur d'Alene, Idaho, 83814
Duke University Medical Center
Durham, North Carolina, 27710
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
University of California, San Diego
San Diego, California, 92037
About this study
Official title: Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)
This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy:
- a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and
- navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.
Read the detailed description
Endpoints:
Primary:
- To evaluate diagnostic accuracy through 12 months of clinical follow-up
Secondary:
- To evaluate rate of pneumothorax.
- To evaluate rate of pneumothorax requiring chest tube placement.
- To evaluate clinically significant bleeding (defined by bleeding requiring intervention).
- To evaluate need for hospitalization after procedure.
- To evaluate duration of the procedure.
- To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site).
- To evaluate need for additional nodule biopsy.
- To evaluate need for additional procedure for staging.
- To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy.
- To evaluate need for F-Nav (digital tomosynthesis) during navigation bronchoscopy.
- To evaluate diagnostic yield
- To evaluate the rate at which the biopsy procedure yields a confident clinical diagnosis (including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens).
- Conditions
- Lung Nodule
- Being tested
- CT-Guided Biopsy, Navigation bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-Guided BiopsyDevice
Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing
Navigation bronchoscopyDevice
A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy
| Study group | Role | What they receive |
|---|---|---|
| Navigation Bronchoscopy (NB) with F-Nav | Experimental | Not described Receives: Device: Navigation bronchoscopy |
| CT-guided Biopsy | Experimental | Not described Receives: Device: CT-Guided Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following:
- Malignant, OR
- Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR
- Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND
- Absence of malignancy (true negative) through 1-year CT follow-up, defined as:
- The nodule markedly regresses or resolves on follow-up imaging, OR
- A persistent nodule has not been diagnosed as malignant, AND
- No plans for repeat invasive diagnostic procedures through 12 months follow-up.
Normal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.
Measured: Up to 12 months
Secondary outcomes (17)
Diagnostic Yield
Rate at which histopathology is obtained which explains the presence of a nodule (according to definitions set forth for the primary endpoint) and permits post-biopsy clinical decision-making without need for immediate additional diagnostic procedures.
Measured: Up to 12 months
Rate of Pneumothorax
Proportion of cases complicated by pneumothorax
Measured: Up to 12 months
Rate of Pneumothorax Requiring Chest Tube Placement
Proportion of cases complicated by pneumothorax requiring chest tube placement
Measured: Up to 12 months
Need for Hospitalization After Procedure
Proportion of cases with complication necessitating hospitalization after a procedure
Measured: Up to 12 months
Duration of Procedure
Total time required to complete the procedure
Measured: Up to 12 months
Procedural Factors Associated With Improved Yield (Type of Biopsy)
Association of diagnostic yield with type of tools used to obtain biopsy: F-Nav Bronchoscopy group. This outcome measure is only applicable to the patients randomized to the navigational bronchoscopy platform.
Measured: Up to 12 months
Procedural Factors Associated With Improved Yield (Number of Biopsies)
Association of diagnostic yield with count of biopsies. This outcome measure is only specific to the F-Nav bronchoscopy arm.
Measured: Up to 12 months
Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound)
Association of diagnostic yield with use of radial ultrasound. This outcome measure is only specific to the F-Nav bronchoscopy arm.
Measured: Up to 12 months
Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign)
Association of diagnostic yield with presence of a bronchus sign
Measured: Up to 12 months
Procedural Factors Associated With Improved Yield (Biopsy Site)
Association of diagnostic yield with biopsy site (nodule location)
Measured: Up to 12 months
Need for Additional Nodule Biopsy
Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed
Measured: Up to 12 months
Need for Additional Procedure for Staging
Proportion of cases in which a subsequent procedure was performed for staging
Measured: Up to 12 months
Radiation Exposure From Fluoroscopy-guided Bronchoscopy
Count of total radiation exposure from fluoroscopy-guided bronchoscopy (units mGy*cm^2)
Measured: Up to 12 months
Need for F-Nav During Navigation Bronchoscopy
Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. This outcome measure pertains only for the F-Nav bronchoscopy arm.
Measured: Up to 12 months
Confident Clinical Diagnosis
The proportion of biopsy procedures yielding a confident clinical diagnosis including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens.
Measured: Up to 12 months
Radiation Exposure From CT for CT-guided Biopsy
Count of total radiation exposure CT-guided transthoracic biopsy (units of mGy*cm)
Measured: Up to 12 months
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group
Association of diagnostic yield with type of tools used to obtain biopsy: CT-guided group. This outcome measure is only applicable to the patients randomized to the CT-guided procedure.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start22 May 2020
- Primary completion10 Jun 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung NoduleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Fabien Maldonado, Vanderbilt-Ingram Cancer Center
- Investigators
- Fabien Maldonado, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250194
- Sponsor's protocol ID
- VICC THO 19102
- Other IDs
- NCI-2020-00632
- Acronym
- VERITAS
- Status last verified
- Sep 2025
- First submitted
- 29 Jan 2020
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Swanner B, Roller L, Low SW, Salmon C, Avasarala SK, Hoopman TC, Wahidi MM, Mahmood K, Cheng GZ, Katsis JM, Kurman JS, D'Haese PF, Johnson J, Grogan EL, Walston C, Yarmus L, Silvestri GA, Rickman OB, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. Navigational Bronchoscopy vs CT Scan-Guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: Protocol and Rationale for the Navigation Endoscopy to Reach Indeterminate Lung Nodules vs Transthoracic Needle Aspiration, a Randomized Controlled Study Multicenter Randomized Trial. CHEST Pulm. 2024 Mar 19;2(3):100050. doi: 10.1016/j.chpulm.2024.100050. eCollection 2024 Sep.
PubMed 42548449Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Avasarala SK, Casey JD, Cheng GZ, D'Haese PF, Duke JD, Grogan EL, Hoopman TC, Johnson J, Katsis JM, Kurman JS, Low SW, Mahmood K, Rickman OB, Roller L, Salmon C, Shojaee S, Swanner B, Wahidi MM, Walston C, Silvestri GA, Yarmus L, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules. N Engl J Med. 2025 Jun 5;392(21):2100-2112. doi: 10.1056/NEJMoa2414059. Epub 2025 May 18.
PubMed 40387025Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Swanner B, Roller L, Low SW, Salmon C, Avasarala SK, Hoopman TC, Wahidi MM, Mahmood K, Cheng GZ, Katsis JM, Kurman JS, D'Haese PF, Johnson J, Grogan EL, Walston C, Yarmus L, Silvestri GA, Rickman OB, Rahman NM, Maldonado F. Navigational Bronchoscopy versus Computed Tomography-guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: protocol and rationale for the VERITAS multicenter randomized trial. medRxiv [Preprint]. 2023 Nov 23:2023.11.22.23298915. doi: 10.1101/2023.11.22.23298915.
PubMed 38045245
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)
- ClinicalTrials.gov ID
- NCT04250194
- Acronym / sponsor ID
- VERITAS / VICC THO 19102
- Conditions
- Lung Nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 22 May 2020 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy:
- a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and
- navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.
Detailed description
Endpoints:
Primary:
- To evaluate diagnostic accuracy through 12 months of clinical follow-up
Secondary:
- To evaluate rate of pneumothorax.
- To evaluate rate of pneumothorax requiring chest tube placement.
- To evaluate clinically significant bleeding (defined by bleeding requiring intervention).
- To evaluate need for hospitalization after procedure.
- To evaluate duration of the procedure.
- To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site).
- To evaluate need for additional nodule biopsy.
- To evaluate need for additional procedure for staging.
- To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy.
- To evaluate need for F-Nav (digital tomosynthesis) during navigation bronchoscopy.
- To evaluate diagnostic yield
- To evaluate the rate at which the biopsy procedure yields a confident clinical diagnosis (including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation Bronchoscopy (NB) with F-Nav | Experimental | Device: Navigation bronchoscopy |
| CT-guided Biopsy | Experimental | Device: CT-Guided Biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy:
Key exclusion criteria (2 listed)
- Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.
- Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).
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 |
|---|---|---|
| CT-Guided BiopsyImages will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing | Device | CT-guided Biopsy |
| Navigation bronchoscopyA virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy | Device | Navigation Bronchoscopy (NB) with F-Nav |
Primary outcome
Diagnostic Accuracy
Time frame: Up to 12 months
Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following: * Malignant, OR * Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR * Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND * Absence of malignancy (true negative) through 1-year CT follow-up, defined as: * The nodule markedly regresses or resolves on follow-up imaging, OR * A persistent nodule has not been diagnosed as malignant, AND * No plans for repeat invasive diagnostic procedures through 12 months follow-up. Normal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.
17 secondary outcomes
Diagnostic Yield
Time frame: Up to 12 months
Rate of Pneumothorax
Time frame: Up to 12 months
Rate of Pneumothorax Requiring Chest Tube Placement
Time frame: Up to 12 months
Need for Hospitalization After Procedure
Time frame: Up to 12 months
Duration of Procedure
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Type of Biopsy)
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Number of Biopsies)
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound)
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign)
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Biopsy Site)
Time frame: Up to 12 months
Need for Additional Nodule Biopsy
Time frame: Up to 12 months
Need for Additional Procedure for Staging
Time frame: Up to 12 months
Radiation Exposure From Fluoroscopy-guided Bronchoscopy
Time frame: Up to 12 months
Need for F-Nav During Navigation Bronchoscopy
Time frame: Up to 12 months
Confident Clinical Diagnosis
Time frame: Up to 12 months
Radiation Exposure From CT for CT-guided Biopsy
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42548449Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Swanner B, Roller L, Low SW, Salmon C, Avasarala SK, Hoopman TC, Wahidi MM, Mahmood K, Cheng GZ, Katsis JM, Kurman JS, D'Haese PF, Johnson J, Grogan EL, Walston C, Yarmus L, Silvestri GA, Rickman OB, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. Navigational Bronchoscopy vs CT Scan-Guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: Protocol and Rationale for the Navigation Endoscopy to Reach Indeterminate Lung Nodules vs Transthoracic Needle Aspiration, a Randomized Controlled Study Multicenter Randomized Trial. CHEST Pulm. 2024 Mar 19;2(3):100050. doi: 10.1016/j.chpulm.2024.100050. eCollection 2024 Sep.
- Derived from this study: PubMed 40387025Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Avasarala SK, Casey JD, Cheng GZ, D'Haese PF, Duke JD, Grogan EL, Hoopman TC, Johnson J, Katsis JM, Kurman JS, Low SW, Mahmood K, Rickman OB, Roller L, Salmon C, Shojaee S, Swanner B, Wahidi MM, Walston C, Silvestri GA, Yarmus L, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules. N Engl J Med. 2025 Jun 5;392(21):2100-2112. doi: 10.1056/NEJMoa2414059. Epub 2025 May 18.
- Derived from this study: PubMed 38045245Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Swanner B, Roller L, Low SW, Salmon C, Avasarala SK, Hoopman TC, Wahidi MM, Mahmood K, Cheng GZ, Katsis JM, Kurman JS, D'Haese PF, Johnson J, Grogan EL, Walston C, Yarmus L, Silvestri GA, Rickman OB, Rahman NM, Maldonado F. Navigational Bronchoscopy versus Computed Tomography-guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: protocol and rationale for the VERITAS multicenter randomized trial. medRxiv [Preprint]. 2023 Nov 23:2023.11.22.23298915. doi: 10.1101/2023.11.22.23298915.
Related trials for Lung Nodule
Active, not recruiting
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Lung Cancer, Lung; Node
Recruiting
Longitudinal AI-Assisted Management of Indeterminate Pulmonary Nodules
Pulmonary Nodules, Lung Neoplasms
Active, not recruitingObservational study
Clinical Application of Artificial Intelligence Methods in Diagnostic Imaging of Pulmonary Nodules
Pulmonary Nodules, Lung Neoplasms
RecruitingObservational study
Study of Collection and Analysis of Clinical, Anamnestic, Functional, Biological Data Through the Support of Artificial Intelligence to Evaluate the Possibility of Defining a Digital Twin of the Lung (LUCE)
Thoracic Neoplasm, Pulmonary Nodules
RecruitingObservational study
Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)
Lung Cancer
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.
Fabien Maldonado, MD principal investigator
Vanderbilt-Ingram Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-Guided Biopsy and Navigation bronchoscopy in people with Lung Nodule, run by Vanderbilt-Ingram Cancer Center at 7 sites in United States.
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 7 inclusion and 2 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnostic Accuracy (time frame: Up to 12 months). 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 NCT04250194, which also lists 3 linked publications.
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 29 Sep 2025.