Peripheral Pulmonary LesionRELIANT 2NCT06654271
Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging
A study testing Robotic assisted bronchoscopy (RAB) and Electromagnetic navigation bronchoscopy (ENB) in people with Peripheral Pulmonary Lesion and Lung Nodule, Solitary, run by Vanderbilt University Medical Center at 4 sites in United States.
Trial summary
RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Lesion, Lung Nodule, Solitary
- What is being tested?
- Robotic assisted bronchoscopy (RAB) and Electromagnetic navigation bronchoscopy (ENB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Nov 2024to 14 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at time of bronchoscopy
- Scheduled for navigational bronchoscopy for the evaluation of a pulmonary lesion
Who cannot join
- Patient declines to participate
- Patients enrolled in another trial which requires the use of one specific navigational platform
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Rush University Medical Center
Chicago, Illinois, 60612
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging: the RELIANT 2 Trial
RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.
Read the detailed description
Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. There are several technologies currently available to biopsy these lesions, including electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB). The latter is used clinically with either conventional fluoroscopy or with cone beam computed tomography (CBCT) guidance, which provides real time 3-dimensional images during the procedure. Recently, CBCT has been integrated with RAB, which allows for automatic update of the lesion location. This update is believed to increase the diagnostic yield of the procedure. Given this new upgrade, we designed this pragmatic, randomized controlled study to test the hypothesis that the diagnostic yield of RAB with integrated CBCT is superior to ENB with integrated digital tomosynthesis in patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Patients undergoing advanced diagnostic bronchoscopy to biopsy a lung lesion will be assigned to either the RAB or ENB based on cluster randomization. Randomization will be revealed each morning before procedures are started. Any advanced diagnostic bronchoscopy scheduled on that day will be performed with the device (RAB or ENB) allocated to that room on that day. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.
- Conditions
- Peripheral Pulmonary Lesion, Lung Nodule, Solitary
- Being tested
- Robotic assisted bronchoscopy (RAB), Electromagnetic navigation bronchoscopy (ENB)
- Keywords
- Electromagnetic navigation bronchoscopy, Robotic assisted bronchoscopy, Cone beam computed tomography, Diagnostic yield
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted bronchoscopy (RAB)Device
Participants allocated to the robotic assisted bronchoscopy arm will undergo robotic assisted bronchoscopy with integrated cone beam computed tomography
Electromagnetic navigation bronchoscopy (ENB)Device
Participants allocated to the electromagnetic navigation bronchoscopy arm will undergo electromagnetic navigation bronchoscopy with integrated digital tomosynthesis
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted bronchoscopy (RAB) | Active comparator | Robotic assisted bronchoscopy with integrated cone beam computed tomography Receives: Device: Robotic assisted bronchoscopy (RAB) |
| Electromagnetic navigation bronchoscopy (ENB) | Active comparator | Electromagnetic navigation bronchoscopy (ENB) with integrated digital tomosynthesis Receives: Device: Electromagnetic navigation bronchoscopy (ENB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified:
- Malignancy
- Specific benign pathologic findings including:
- Organizing pneumonia
- Frank purulence/robust neutrophilic inflammation
- Granulomatous inflammation
- Other specific benign findings such as hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns as adjudicated by an expert lung pathologist.
Measured: 7 days post-procedure
Secondary outcomes (1)
Duration of bronchoscopy (in minutes)
Defined as time from the start of airway registration to the removal of the bronchoscope after completion of navigation procedures
Measured: Duration of procedure, approximately 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start11 Nov 2024
- Primary completion14 Oct 2025
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Peripheral Pulmonary LesionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be performed as a pragmatic, cluster randomized controlled trial with parallel group assignment.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Paez, Vanderbilt University Medical Center
- Investigators
- Rafael Paez, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654271
- Sponsor's protocol ID
- 241103
- Acronym
- RELIANT 2
- Status last verified
- Oct 2025
- First submitted
- 21 Oct 2024
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be made available after de-identification.
Publications
Zhang C, Xie F, Li R, Cui N, Herth FJF, Sun J. Robotic-assisted bronchoscopy for the diagnosis of peripheral pulmonary lesions: A systematic review and meta-analysis. Thorac Cancer. 2024 Mar;15(7):505-512. doi: 10.1111/1759-7714.15229. Epub 2024 Jan 29.
PubMed 38286133Kalchiem-Dekel O, Connolly JG, Lin IH, Husta BC, Adusumilli PS, Beattie JA, Buonocore DJ, Dycoco J, Fuentes P, Jones DR, Lee RP, Park BJ, Rocco G, Chawla M, Bott MJ. Shape-Sensing Robotic-Assisted Bronchoscopy in the Diagnosis of Pulmonary Parenchymal Lesions. Chest. 2022 Feb;161(2):572-582. doi: 10.1016/j.chest.2021.07.2169. Epub 2021 Aug 9.
PubMed 34384789Low SW, Lentz RJ, Chen H, Katsis J, Aboudara MC, Whatley S, Paez R, Rickman OB, Maldonado F. Shape-Sensing Robotic-Assisted Bronchoscopy vs Digital Tomosynthesis-Corrected Electromagnetic Navigation Bronchoscopy: A Comparative Cohort Study of Diagnostic Performance. Chest. 2023 Apr;163(4):977-984. doi: 10.1016/j.chest.2022.10.019. Epub 2022 Oct 29.
PubMed 36441041Katsis J, Roller L, Aboudara M, Pannu J, Chen H, Johnson J, Lentz RJ, Rickman O, Maldonado F. Diagnostic Yield of Digital Tomosynthesis-assisted Navigational Bronchoscopy for Indeterminate Lung Nodules. J Bronchology Interv Pulmonol. 2021 Oct 1;28(4):255-261. doi: 10.1097/LBR.0000000000000766.
PubMed 33734149Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, Kosco AE, Di Fiore JL, Suh DE. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505-0990OC.
PubMed 26214244Nadig TR, Thomas N, Nietert PJ, Lozier J, Tanner NT, Wang Memoli JS, Pastis NJ, Silvestri GA. Guided Bronchoscopy for the Evaluation of Pulmonary Lesions: An Updated Meta-analysis. Chest. 2023 Jun;163(6):1589-1598. doi: 10.1016/j.chest.2022.12.044. Epub 2023 Jan 11.
PubMed 36640994Criner GJ, Eberhardt R, Fernandez-Bussy S, Gompelmann D, Maldonado F, Patel N, Shah PL, Slebos DJ, Valipour A, Wahidi MM, Weir M, Herth FJ. Interventional Bronchoscopy. Am J Respir Crit Care Med. 2020 Jul 1;202(1):29-50. doi: 10.1164/rccm.201907-1292SO.
PubMed 32023078Agrawal A, Hogarth DK, Murgu S. Robotic bronchoscopy for pulmonary lesions: a review of existing technologies and clinical data. J Thorac Dis. 2020 Jun;12(6):3279-3286. doi: 10.21037/jtd.2020.03.35.
PubMed 32642251Aboudara M, Roller L, Rickman O, Lentz RJ, Pannu J, Chen H, Maldonado F. Improved diagnostic yield for lung nodules with digital tomosynthesis-corrected navigational bronchoscopy: Initial experience with a novel adjunct. Respirology. 2020 Feb;25(2):206-213. doi: 10.1111/resp.13609. Epub 2019 Jul 2.
PubMed 31265204Styrvoky K, Schwalk A, Pham D, Madsen K, Chiu HT, Abu-Hijleh M. Radiation dose of cone beam CT combined with shape sensing robotic assisted bronchoscopy for the evaluation of pulmonary lesions: an observational single center study. J Thorac Dis. 2023 Sep 28;15(9):4836-4848. doi: 10.21037/jtd-23-587. Epub 2023 Aug 30.
PubMed 37868864Paez R, Ratwani AP, Duke JD, Bridwell G, Leonard K, Katsis JM, Pickering EM, Thiboutot J, Chen H, Chen SC, Shojaee S, Yarmus L, Lentz RJ, Maldonado F; Interventional Pulmonary Outcomes Group. Robotic versus electromagnetic bronchoscopy for pulmonary leslon assessment using integrated intraprocedural imaging: Study protocol for the reliant 2 trial. PLoS One. 2025 Dec 3;20(12):e0327611. doi: 10.1371/journal.pone.0327611. eCollection 2025.
PubMed 41336287Chen SC, Chen H, Paez R, Gatto CL, Lentz RJ, Maldonado F. A randomization strategy for a cluster-randomized controlled trial with variable operating room availability. Contemp Clin Trials. 2025 Oct;157:108057. doi: 10.1016/j.cct.2025.108057. Epub 2025 Aug 28.
PubMed 40885487
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging: the RELIANT 2 Trial
- ClinicalTrials.gov ID
- NCT06654271
- Acronym / sponsor ID
- RELIANT 2 / 241103
- Conditions
- Peripheral Pulmonary Lesion, Lung Nodule, Solitary
- Keywords
- Electromagnetic navigation bronchoscopy, Robotic assisted bronchoscopy, Cone beam computed tomography, Diagnostic yield
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 23 Oct 2024 (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.
RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.
Detailed description
Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. There are several technologies currently available to biopsy these lesions, including electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB). The latter is used clinically with either conventional fluoroscopy or with cone beam computed tomography (CBCT) guidance, which provides real time 3-dimensional images during the procedure. Recently, CBCT has been integrated with RAB, which allows for automatic update of the lesion location. This update is believed to increase the diagnostic yield of the procedure. Given this new upgrade, we designed this pragmatic, randomized controlled study to test the hypothesis that the diagnostic yield of RAB with integrated CBCT is superior to ENB with integrated digital tomosynthesis in patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Patients undergoing advanced diagnostic bronchoscopy to biopsy a lung lesion will be assigned to either the RAB or ENB based on cluster randomization. Randomization will be revealed each morning before procedures are started. Any advanced diagnostic bronchoscopy scheduled on that day will be performed with the device (RAB or ENB) allocated to that room on that day. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be performed as a pragmatic, cluster randomized controlled trial with parallel group assignment.
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted bronchoscopy (RAB) | Active comparator | Device: Robotic assisted bronchoscopy (RAB)Robotic assisted bronchoscopy with integrated cone beam computed tomography |
| Electromagnetic navigation bronchoscopy (ENB) | Active comparator | Device: Electromagnetic navigation bronchoscopy (ENB)Electromagnetic navigation bronchoscopy (ENB) with integrated digital tomosynthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years of age at time of bronchoscopy
- Scheduled for navigational bronchoscopy for the evaluation of a pulmonary lesion
Key exclusion criteria (2 listed)
- Patient declines to participate
- Patients enrolled in another trial which requires the use of one specific navigational platform
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 |
|---|---|---|
| Robotic assisted bronchoscopy (RAB)Participants allocated to the robotic assisted bronchoscopy arm will undergo robotic assisted bronchoscopy with integrated cone beam computed tomography | Device | Robotic assisted bronchoscopy (RAB) |
| Electromagnetic navigation bronchoscopy (ENB)Participants allocated to the electromagnetic navigation bronchoscopy arm will undergo electromagnetic navigation bronchoscopy with integrated digital tomosynthesis | Device | Electromagnetic navigation bronchoscopy (ENB) |
Primary outcome
The primary endpoint is the diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
Time frame: 7 days post-procedure
Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified: * Malignancy * Specific benign pathologic findings including: * Organizing pneumonia * Frank purulence/robust neutrophilic inflammation * Granulomatous inflammation * Other specific benign findings such as hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns as adjudicated by an expert lung pathologist.
1 secondary outcome
Duration of bronchoscopy (in minutes)
Time frame: Duration of procedure, approximately 60 minutes
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 20 Oct 2025.
- Background: PubMed 38286133Zhang C, Xie F, Li R, Cui N, Herth FJF, Sun J. Robotic-assisted bronchoscopy for the diagnosis of peripheral pulmonary lesions: A systematic review and meta-analysis. Thorac Cancer. 2024 Mar;15(7):505-512. doi: 10.1111/1759-7714.15229. Epub 2024 Jan 29.
- Background: PubMed 34384789Kalchiem-Dekel O, Connolly JG, Lin IH, Husta BC, Adusumilli PS, Beattie JA, Buonocore DJ, Dycoco J, Fuentes P, Jones DR, Lee RP, Park BJ, Rocco G, Chawla M, Bott MJ. Shape-Sensing Robotic-Assisted Bronchoscopy in the Diagnosis of Pulmonary Parenchymal Lesions. Chest. 2022 Feb;161(2):572-582. doi: 10.1016/j.chest.2021.07.2169. Epub 2021 Aug 9.
- Background: PubMed 36441041Low SW, Lentz RJ, Chen H, Katsis J, Aboudara MC, Whatley S, Paez R, Rickman OB, Maldonado F. Shape-Sensing Robotic-Assisted Bronchoscopy vs Digital Tomosynthesis-Corrected Electromagnetic Navigation Bronchoscopy: A Comparative Cohort Study of Diagnostic Performance. Chest. 2023 Apr;163(4):977-984. doi: 10.1016/j.chest.2022.10.019. Epub 2022 Oct 29.
- Background: PubMed 33734149Katsis J, Roller L, Aboudara M, Pannu J, Chen H, Johnson J, Lentz RJ, Rickman O, Maldonado F. Diagnostic Yield of Digital Tomosynthesis-assisted Navigational Bronchoscopy for Indeterminate Lung Nodules. J Bronchology Interv Pulmonol. 2021 Oct 1;28(4):255-261. doi: 10.1097/LBR.0000000000000766.
- Background: PubMed 26214244Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, Kosco AE, Di Fiore JL, Suh DE. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505-0990OC.
- Background: PubMed 36640994Nadig TR, Thomas N, Nietert PJ, Lozier J, Tanner NT, Wang Memoli JS, Pastis NJ, Silvestri GA. Guided Bronchoscopy for the Evaluation of Pulmonary Lesions: An Updated Meta-analysis. Chest. 2023 Jun;163(6):1589-1598. doi: 10.1016/j.chest.2022.12.044. Epub 2023 Jan 11.
- Background: PubMed 32023078Criner GJ, Eberhardt R, Fernandez-Bussy S, Gompelmann D, Maldonado F, Patel N, Shah PL, Slebos DJ, Valipour A, Wahidi MM, Weir M, Herth FJ. Interventional Bronchoscopy. Am J Respir Crit Care Med. 2020 Jul 1;202(1):29-50. doi: 10.1164/rccm.201907-1292SO.
- Background: PubMed 32642251Agrawal A, Hogarth DK, Murgu S. Robotic bronchoscopy for pulmonary lesions: a review of existing technologies and clinical data. J Thorac Dis. 2020 Jun;12(6):3279-3286. doi: 10.21037/jtd.2020.03.35.
- Background: PubMed 31265204Aboudara M, Roller L, Rickman O, Lentz RJ, Pannu J, Chen H, Maldonado F. Improved diagnostic yield for lung nodules with digital tomosynthesis-corrected navigational bronchoscopy: Initial experience with a novel adjunct. Respirology. 2020 Feb;25(2):206-213. doi: 10.1111/resp.13609. Epub 2019 Jul 2.
- Background: PubMed 37868864Styrvoky K, Schwalk A, Pham D, Madsen K, Chiu HT, Abu-Hijleh M. Radiation dose of cone beam CT combined with shape sensing robotic assisted bronchoscopy for the evaluation of pulmonary lesions: an observational single center study. J Thorac Dis. 2023 Sep 28;15(9):4836-4848. doi: 10.21037/jtd-23-587. Epub 2023 Aug 30.
- Derived from this study: PubMed 41336287Paez R, Ratwani AP, Duke JD, Bridwell G, Leonard K, Katsis JM, Pickering EM, Thiboutot J, Chen H, Chen SC, Shojaee S, Yarmus L, Lentz RJ, Maldonado F; Interventional Pulmonary Outcomes Group. Robotic versus electromagnetic bronchoscopy for pulmonary leslon assessment using integrated intraprocedural imaging: Study protocol for the reliant 2 trial. PLoS One. 2025 Dec 3;20(12):e0327611. doi: 10.1371/journal.pone.0327611. eCollection 2025.
- Derived from this study: PubMed 40885487Chen SC, Chen H, Paez R, Gatto CL, Lentz RJ, Maldonado F. A randomization strategy for a cluster-randomized controlled trial with variable operating room availability. Contemp Clin Trials. 2025 Oct;157:108057. doi: 10.1016/j.cct.2025.108057. Epub 2025 Aug 28.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be made available after de-identification.
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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.
Rafael Paez, MD principal investigator
Vanderbilt University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assisted bronchoscopy (RAB) and Electromagnetic navigation bronchoscopy (ENB) in people with Peripheral Pulmonary Lesion and Lung Nodule, Solitary, run by Vanderbilt University Medical Center at 4 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 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
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?
The primary endpoint is the diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue. (time frame: 7 days post-procedure). 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 NCT06654271, which also lists 12 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 20 Oct 2025.