Peripheral Pulmonary Lesions (PPLs)SERENENCT07411989
Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions
A study testing Bronchoscopy for peripheral pulmonary lesion biopsy in people with Peripheral Pulmonary Lesions (PPLs) and Lung Nodules, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
This is an investigator-initiated, multicenter, non inferiority, cluster randomized controlled trial. The primary objective is to compare the diagnostic yield of the electromagnetic robotic assisted bronchoscopy with digital tomosynthesis (Galaxy system by Noah Medical) to the shape sensing robotic assisted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Lesions (PPLs), Lung Nodules
- What is being tested?
- Bronchoscopy for peripheral pulmonary lesion biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2026to Dec 2028
- 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 pulmonary lesion
Who cannot join
- 1. Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
The Cleveland Clinic
Cleveland, Ohio, 44195
See-Wei Low, MD, 216-445-0570, LOWS5@ccf.org
Michael Machuzak, MD
About this study
Official title: Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions: the SERENE Trial
This is an investigator-initiated, multicenter, non inferiority, cluster randomized controlled trial. The primary objective is to compare the diagnostic yield of the electromagnetic robotic assisted bronchoscopy with digital tomosynthesis (Galaxy system by Noah Medical) to the shape sensing robotic assisted bronchoscopy with integrated cone beam CT (Ion™ Endoluminal System by Intuitive) in patients undergoing bronchoscopy for peripheral pulmonary lesion (PPL) evaluation.
Read the detailed description
Millions of nodules are detected every year in the United States. The majority are benign, but some represent early lung cancer and biopsy is often needed to establish the diagnosis. Advanced imaging and navigational guidance systems are routinely used to sample these small peripheral lesions bronchoscopically.
A variety of navigational technologies are currently available, including non-robotic electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB), both cleared by the FDA via the 510(k) pathway. Since market release in 2019, few studies, mostly retrospective and observational studies have reported on the diagnostic yield of RAB which is estimated to be approximately 75-80%. Most of these procedures were performed using conventional fluoroscopy which provides a two-dimensional image to assist with location of the bronchoscope within the chest and with biopsy. However, pulmonary nodules are frequently not visible with conventional fluoroscopy, particularly subsolid or ground glass nodules, which may contribute to non-diagnostic procedures. Thus, the combination of RAB with CBCT, a three-dimensional cross-sectional imaging modality, has been widely adopted by the interventional pulmonology and advanced bronchoscopy community. Cone beam CT produces a near real-time intraprocedural CT image that allows the proceduralist to reposition the robotic bronchoscope based on the location of the bronchoscope relative to that of the nodule and minimize CT to body divergence (CT2BD). Preliminary data suggest that addition of CBCT improves the diagnostic yield. One of the RAB platforms (ssRAB by Intuitive) is now integrated with CBCT, which allows the proceduralist to update the position of the nodule in the navigation system itself. This upgrade is believed to increase the diagnostic yield of ssRAB.
The Galaxy System (Noah Medical) is the latest robotic bronchoscopy platform that integrates its digital tomosynthesis (DT) technology with electromagnetic navigation (EMN) robotic platform with continuous vision. DT is an imaging modality whereby a series of fluoroscopic digital images taken during a partial rotational sweep of a C-arm are superimposed and computationally processed to provide a final three-dimensional image in which the lesion of interest can be far more readily seen than by standard fluoroscopic screening whilst minimizing radiation exposure compared, for example, to CBCT. This new generation Image-Integrated Robotic Assisted Bronchoscopy (ii-RAB) utilizes the advantages of the stability of a robotic bronchoscopy and mitigates CT2BD with imaging confirmation that demonstrates the biopsy tool inside the lesion.
The current assumed pros of using the Galaxy system compared to ssRAB with integrated CBCT is that the procedure may be shorter in time with less use of radiation to the patient and staffs. While the potential downside of the use of DT only without CBCT is that it may be less accurate.
As there are no randomized or retrospective comparative data comparing the two robotic bronchoscopy platforms despite being commercially available and widely utilized, the investigators propose to compare the diagnostic yield of the newest electromagnetic RAB (E-RAB) with integrated digital tomosynthesis (DT) to that of ssRAB with integrated CBCT. Cleveland Clinic and RUSH University currently utilizes both E-RAB with DT and ssRAB with integrated CBCT and they are used interchangeably. Patients are typically assigned arbitrarily to procedures using either platform based on operating room availability.
Thus, the investigator proposes a randomized controlled study to test the hypothesis that the diagnostic yield of E-RAB with DT is not inferior to ssRAB with integrated CBCT in patients undergoing bronchoscopy to biopsy a PPL.
- Conditions
- Peripheral Pulmonary Lesions (PPLs), Lung Nodules
- Being tested
- Bronchoscopy for peripheral pulmonary lesion biopsy
- Keywords
- Bronchoscopy, Peripheral Pulmonary Lesions, Robotic assisted bronchoscopy, Lung biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy for peripheral pulmonary lesion biopsyProcedure or surgery
Participants are scheduled to undergo a bronchoscopy as part of their routine standard of care. Participants will be randomly assigned to one of our two standards of care bronchoscopy robotic platforms (Ion shape sensing robot or Galaxy by Noah electromagnetic robot).
| Study group | Role | What they receive |
|---|---|---|
| Ion™ Endoluminal System (shape sensing RAB) | Active comparator | Providers will utilize the Ion™ Endoluminal System (shape sensing RAB) to perform a diagnostic bronchoscopy procedure. Receives: Procedure: Bronchoscopy for peripheral pulmonary lesion biopsy |
| Galaxy by Noah (EMN-RAB) | Active comparator | Providers will utilize the Galaxy by Noah (EMN-RAB) to perform a diagnostic bronchoscopy procedure. Receives: Procedure: Bronchoscopy for peripheral pulmonary lesion biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Diagnostic yield is defined as the proportion of procedures that results in acquisition of lesional tissue. Lesional tissue is defined by the presence of histopathological findings that readily explain the presence of a pulmonary lesion.
The following common histopathological findings are pre-specified as lesional:
- Malignant ii. "Specific benign" findings accounting for the presence of a PPL
- organizing pneumonia
- purulence
- granulomatous inflammation
- hamartoma
- amyloidoma Procedures with non-specific inflammation, normal tissue, atypia not diagnostic of malignancy, or where no biopsy is obtained due to navigation failure, complication, or equipment failure are non-diagnostic. Only guided bronchoscopy biopsies from the first target lesion are included; non-malignant samples are reviewed by a blinded panel.
Measured: 7 days post enrollment
Secondary outcomes (1)
Radiation Exposure During Study Bronchoscopy
Radiation exposure is defined as the radiation dose delivered to the patient during the study bronchoscopy, recorded as the dose area product (mGy·cm²). Only radiation directly associated with the index bronchoscopy procedure will be included.
Measured: During the bronchoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Peripheral Pulmonary Lesions (PPLs)Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Cluster randomization will be used for this study using bronchoscopy room-days as clusters, given the impracticability of individual-level randomization. Clusters will be randomized to either ssRAB with integrated CBCT or E-RAB with integrated DT. Randomization will be completed in permuted blocks of variable size stratified by room availability.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center
- Responsible party
- Principal investigator, See-Wei Low, The Cleveland Clinic
- Investigators
- See-Wei Low, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411989
- Sponsor's protocol ID
- 26-119
- Acronym
- SERENE
- Status last verified
- May 2026
- First submitted
- 4 Feb 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
Publications
Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.
PubMed 26367186Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Gonzalez AV, Silvestri GA, Korevaar DA, Gesthalter YB, Almeida ND, Chen A, Gilbert CR, Illei PB, Navani N, Pasquinelli MM, Pastis NJ, Sears CR, Shojaee S, Solomon SB, Steinfort DP, Maldonado F, Rivera MP, Yarmus LB. Assessment of Advanced Diagnostic Bronchoscopy Outcomes for Peripheral Lung Lesions: A Delphi Consensus Definition of Diagnostic Yield and Recommendations for Patient-centered Study Designs. An Official American Thoracic Society/American College of Chest Physicians Research Statement. Am J Respir Crit Care Med. 2024 Mar 15;209(6):634-646. doi: 10.1164/rccm.202401-0192ST.
PubMed 38394646Paez R, Lentz RJ, Duke JD, Siemann JK, Salmon C, Dahlberg GJ, Ratwani AP, Casey JD, Chen H, Chen SC, Shojaee S, Rickman OB, Gatto CL, Rice TW, Maldonado F. Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT). Am J Respir Crit Care Med. 2025 Sep;211(9):1644-1651. doi: 10.1164/rccm.202409-1846OC.
PubMed 40460390Saghaie T, Williamson JP, Phillips M, Kafili D, Sundar S, Hogarth DK, Ing A. First-in-human use of a new robotic electromagnetic navigation bronchoscopic platform with integrated Tool-in-Lesion Tomosynthesis (TiLT) technology for peripheral pulmonary lesions: The FRONTIER study. Respirology. 2024 Nov;29(11):969-975. doi: 10.1111/resp.14778. Epub 2024 Jun 24.
PubMed 38923084Bhadra K, Rickman OB, Mahajan AK, Hogarth DK. "Tool-in-lesion" Accuracy of Galaxy System-A Robotic Electromagnetic Navigation BroncHoscopy With Integrated Tool-in-lesion-Tomosynthesis Technology: The MATCH Study. J Bronchology Interv Pulmonol. 2024 Jan 1;31(1):23-29. doi: 10.1097/LBR.0000000000000923.
PubMed 37072895Pritchett MA, Bhadra K, Mattingley JS. Electromagnetic Navigation Bronchoscopy With Tomosynthesis-based Visualization and Positional Correction: Three-dimensional Accuracy as Confirmed by Cone-Beam Computed Tomography. J Bronchology Interv Pulmonol. 2021 Jan 1;28(1):10-20. doi: 10.1097/LBR.0000000000000687.
PubMed 32412920Ferrari A, Bertolaccini L, Solli P, Di Salvia PO, Scaradozzi D. Digital chest tomosynthesis: the 2017 updated review of an emerging application. Ann Transl Med. 2018 Mar;6(5):91. doi: 10.21037/atm.2017.08.18.
PubMed 29666814Styrvoky 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 37868864Reisenauer J, Duke JD, Kern R, Fernandez-Bussy S, Edell E. Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2022 Apr 23;6(3):177-185. doi: 10.1016/j.mayocpiqo.2022.02.004. eCollection 2022 Jun.
PubMed 35509435Abia-Trujillo D, Folch EE, Yu Lee-Mateus A, Balasubramanian P, Kheir F, Keyes CM, Villalobos R, Chadha RM, Hazelett BN, Fernandez-Bussy S. Mobile cone-beam computed tomography complementing shape-sensing robotic-assisted bronchoscopy in the small pulmonary nodule sampling: A multicentre experience. Respirology. 2024 Apr;29(4):324-332. doi: 10.1111/resp.14626. Epub 2023 Nov 28.
PubMed 38016646Avasarala SK, Roller L, Katsis J, Chen H, Lentz RJ, Rickman OB, Maldonado F. Sight Unseen: Diagnostic Yield and Safety Outcomes of a Novel Multimodality Navigation Bronchoscopy Platform with Real-Time Target Acquisition. Respiration. 2022;101(2):166-173. doi: 10.1159/000518009. Epub 2021 Sep 3.
PubMed 34515222Aboudara 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 31265204Low 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 36441041Kalchiem-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 34384789
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions: the SERENE Trial
- ClinicalTrials.gov ID
- NCT07411989
- Acronym / sponsor ID
- SERENE / 26-119
- Conditions
- Peripheral Pulmonary Lesions (PPLs), Lung Nodules
- Keywords
- Bronchoscopy, Peripheral Pulmonary Lesions, Robotic assisted bronchoscopy, Lung biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Rush University Medical Center
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Feb 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 an investigator-initiated, multicenter, non inferiority, cluster randomized controlled trial. The primary objective is to compare the diagnostic yield of the electromagnetic robotic assisted bronchoscopy with digital tomosynthesis (Galaxy system by Noah Medical) to the shape sensing robotic assisted bronchoscopy with integrated cone beam CT (Ion™ Endoluminal System by Intuitive) in patients undergoing bronchoscopy for peripheral pulmonary lesion (PPL) evaluation.
Detailed description
Millions of nodules are detected every year in the United States. The majority are benign, but some represent early lung cancer and biopsy is often needed to establish the diagnosis. Advanced imaging and navigational guidance systems are routinely used to sample these small peripheral lesions bronchoscopically.
A variety of navigational technologies are currently available, including non-robotic electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB), both cleared by the FDA via the 510(k) pathway. Since market release in 2019, few studies, mostly retrospective and observational studies have reported on the diagnostic yield of RAB which is estimated to be approximately 75-80%. Most of these procedures were performed using conventional fluoroscopy which provides a two-dimensional image to assist with location of the bronchoscope within the chest and with biopsy. However, pulmonary nodules are frequently not visible with conventional fluoroscopy, particularly subsolid or ground glass nodules, which may contribute to non-diagnostic procedures. Thus, the combination of RAB with CBCT, a three-dimensional cross-sectional imaging modality, has been widely adopted by the interventional pulmonology and advanced bronchoscopy community. Cone beam CT produces a near real-time intraprocedural CT image that allows the proceduralist to reposition the robotic bronchoscope based on the location of the bronchoscope relative to that of the nodule and minimize CT to body divergence (CT2BD). Preliminary data suggest that addition of CBCT improves the diagnostic yield. One of the RAB platforms (ssRAB by Intuitive) is now integrated with CBCT, which allows the proceduralist to update the position of the nodule in the navigation system itself. This upgrade is believed to increase the diagnostic yield of ssRAB.
The Galaxy System (Noah Medical) is the latest robotic bronchoscopy platform that integrates its digital tomosynthesis (DT) technology with electromagnetic navigation (EMN) robotic platform with continuous vision. DT is an imaging modality whereby a series of fluoroscopic digital images taken during a partial rotational sweep of a C-arm are superimposed and computationally processed to provide a final three-dimensional image in which the lesion of interest can be far more readily seen than by standard fluoroscopic screening whilst minimizing radiation exposure compared, for example, to CBCT. This new generation Image-Integrated Robotic Assisted Bronchoscopy (ii-RAB) utilizes the advantages of the stability of a robotic bronchoscopy and mitigates CT2BD with imaging confirmation that demonstrates the biopsy tool inside the lesion.
The current assumed pros of using the Galaxy system compared to ssRAB with integrated CBCT is that the procedure may be shorter in time with less use of radiation to the patient and staffs. While the potential downside of the use of DT only without CBCT is that it may be less accurate.
As there are no randomized or retrospective comparative data comparing the two robotic bronchoscopy platforms despite being commercially available and widely utilized, the investigators propose to compare the diagnostic yield of the newest electromagnetic RAB (E-RAB) with integrated digital tomosynthesis (DT) to that of ssRAB with integrated CBCT. Cleveland Clinic and RUSH University currently utilizes both E-RAB with DT and ssRAB with integrated CBCT and they are used interchangeably. Patients are typically assigned arbitrarily to procedures using either platform based on operating room availability.
Thus, the investigator proposes a randomized controlled study to test the hypothesis that the diagnostic yield of E-RAB with DT is not inferior to ssRAB with integrated CBCT in patients undergoing bronchoscopy to biopsy a PPL.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomization will be used for this study using bronchoscopy room-days as clusters, given the impracticability of individual-level randomization. Clusters will be randomized to either ssRAB with integrated CBCT or E-RAB with integrated DT. Randomization will be completed in permuted blocks of variable size stratified by room availability.
| Arm | Type | Receives |
|---|---|---|
| Ion™ Endoluminal System (shape sensing RAB) | Active comparator | Procedure: Bronchoscopy for peripheral pulmonary lesion biopsyProviders will utilize the Ion™ Endoluminal System (shape sensing RAB) to perform a diagnostic bronchoscopy procedure. |
| Galaxy by Noah (EMN-RAB) | Active comparator | Procedure: Bronchoscopy for peripheral pulmonary lesion biopsyProviders will utilize the Galaxy by Noah (EMN-RAB) to perform a diagnostic bronchoscopy procedure. |
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 pulmonary lesion
Key exclusion criteria (1 listed)
- 1. Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopy for peripheral pulmonary lesion biopsyParticipants are scheduled to undergo a bronchoscopy as part of their routine standard of care. Participants will be randomly assigned to one of our two standards of care bronchoscopy robotic platforms (Ion shape sensing robot or Galaxy by Noah electromagnetic robot). | Procedure or surgery | Galaxy by Noah (EMN-RAB), Ion™ Endoluminal System (shape sensing RAB) |
Primary outcome
Diagnostic yield
Time frame: 7 days post enrollment
Diagnostic yield is defined as the proportion of procedures that results in acquisition of lesional tissue. Lesional tissue is defined by the presence of histopathological findings that readily explain the presence of a pulmonary lesion. The following common histopathological findings are pre-specified as lesional: i. Malignant ii. "Specific benign" findings accounting for the presence of a PPL * organizing pneumonia * purulence * granulomatous inflammation * hamartoma * amyloidoma Procedures with non-specific inflammation, normal tissue, atypia not diagnostic of malignancy, or where no biopsy is obtained due to navigation failure, complication, or equipment failure are non-diagnostic. Only guided bronchoscopy biopsies from the first target lesion are included; non-malignant samples are reviewed by a blinded panel.
1 secondary outcome
Radiation Exposure During Study Bronchoscopy
Time frame: During the bronchoscopy procedure
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 May 2026.
- Background: PubMed 26367186Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 38394646Gonzalez AV, Silvestri GA, Korevaar DA, Gesthalter YB, Almeida ND, Chen A, Gilbert CR, Illei PB, Navani N, Pasquinelli MM, Pastis NJ, Sears CR, Shojaee S, Solomon SB, Steinfort DP, Maldonado F, Rivera MP, Yarmus LB. Assessment of Advanced Diagnostic Bronchoscopy Outcomes for Peripheral Lung Lesions: A Delphi Consensus Definition of Diagnostic Yield and Recommendations for Patient-centered Study Designs. An Official American Thoracic Society/American College of Chest Physicians Research Statement. Am J Respir Crit Care Med. 2024 Mar 15;209(6):634-646. doi: 10.1164/rccm.202401-0192ST.
- Background: PubMed 40460390Paez R, Lentz RJ, Duke JD, Siemann JK, Salmon C, Dahlberg GJ, Ratwani AP, Casey JD, Chen H, Chen SC, Shojaee S, Rickman OB, Gatto CL, Rice TW, Maldonado F. Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT). Am J Respir Crit Care Med. 2025 Sep;211(9):1644-1651. doi: 10.1164/rccm.202409-1846OC.
- Background: PubMed 38923084Saghaie T, Williamson JP, Phillips M, Kafili D, Sundar S, Hogarth DK, Ing A. First-in-human use of a new robotic electromagnetic navigation bronchoscopic platform with integrated Tool-in-Lesion Tomosynthesis (TiLT) technology for peripheral pulmonary lesions: The FRONTIER study. Respirology. 2024 Nov;29(11):969-975. doi: 10.1111/resp.14778. Epub 2024 Jun 24.
- Background: PubMed 37072895Bhadra K, Rickman OB, Mahajan AK, Hogarth DK. "Tool-in-lesion" Accuracy of Galaxy System-A Robotic Electromagnetic Navigation BroncHoscopy With Integrated Tool-in-lesion-Tomosynthesis Technology: The MATCH Study. J Bronchology Interv Pulmonol. 2024 Jan 1;31(1):23-29. doi: 10.1097/LBR.0000000000000923.
- Background: PubMed 32412920Pritchett MA, Bhadra K, Mattingley JS. Electromagnetic Navigation Bronchoscopy With Tomosynthesis-based Visualization and Positional Correction: Three-dimensional Accuracy as Confirmed by Cone-Beam Computed Tomography. J Bronchology Interv Pulmonol. 2021 Jan 1;28(1):10-20. doi: 10.1097/LBR.0000000000000687.
- Background: PubMed 29666814Ferrari A, Bertolaccini L, Solli P, Di Salvia PO, Scaradozzi D. Digital chest tomosynthesis: the 2017 updated review of an emerging application. Ann Transl Med. 2018 Mar;6(5):91. doi: 10.21037/atm.2017.08.18.
- 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.
- Background: PubMed 35509435Reisenauer J, Duke JD, Kern R, Fernandez-Bussy S, Edell E. Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2022 Apr 23;6(3):177-185. doi: 10.1016/j.mayocpiqo.2022.02.004. eCollection 2022 Jun.
- Background: PubMed 38016646Abia-Trujillo D, Folch EE, Yu Lee-Mateus A, Balasubramanian P, Kheir F, Keyes CM, Villalobos R, Chadha RM, Hazelett BN, Fernandez-Bussy S. Mobile cone-beam computed tomography complementing shape-sensing robotic-assisted bronchoscopy in the small pulmonary nodule sampling: A multicentre experience. Respirology. 2024 Apr;29(4):324-332. doi: 10.1111/resp.14626. Epub 2023 Nov 28.
- Background: PubMed 34515222Avasarala SK, Roller L, Katsis J, Chen H, Lentz RJ, Rickman OB, Maldonado F. Sight Unseen: Diagnostic Yield and Safety Outcomes of a Novel Multimodality Navigation Bronchoscopy Platform with Real-Time Target Acquisition. Respiration. 2022;101(2):166-173. doi: 10.1159/000518009. Epub 2021 Sep 3.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be made available (including data dictionaries) 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.
See-Wei Low, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy for peripheral pulmonary lesion biopsy in people with Peripheral Pulmonary Lesions (PPLs) and Lung Nodules, run by The Cleveland Clinic at 2 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 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact See-Wei Low, MD (216 445-0570, LOWS5@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: 7 days post enrollment). 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 NCT07411989, which also lists 19 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 28 May 2026.