Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions (SERENE)

May 26, 2026 updated by: See-Wei Low, The Cleveland Clinic

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

346

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: See-Wei Low, MD
  • Phone Number: 216 445-0570
  • Email: LOWS5@ccf.org

Study Contact Backup

  • Name: Yvonne Meli, RN
  • Phone Number: 216 445-4215
  • Email: MELIY@ccf.org

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
        • Sub-Investigator:
          • Michael Machuzak, MD
        • Sub-Investigator:
          • Joseph Cicenia, MD
        • Sub-Investigator:
          • Louis Lam, MD
        • Sub-Investigator:
          • Sonali Sethi, MD
        • Sub-Investigator:
          • Colin Gillespie, MD
        • Sub-Investigator:
          • Marcela Azevedo, MD
        • Sub-Investigator:
          • Christopher Di Felice, MD
        • Sub-Investigator:
          • Grant Senyei, MD
        • Sub-Investigator:
          • Sangita Goel, MD
        • Sub-Investigator:
          • Bryan Benn, MD, PhD
        • Contact:
          • See-Wei Low, MD
          • Phone Number: 216-445-0570
          • Email: LOWS5@ccf.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥ 18 years of age at time of bronchoscopy
  2. Scheduled for navigational bronchoscopy for the evaluation of pulmonary lesion

Exclusion Criteria:

1. Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ion™ Endoluminal System (shape sensing RAB)
Providers will utilize the Ion™ Endoluminal System (shape sensing RAB) to perform a diagnostic bronchoscopy procedure.
Procedure: Bronchoscopy for peripheral pulmonary lesion biopsy
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).
Active Comparator: Galaxy by Noah (EMN-RAB)
Providers will utilize the Galaxy by Noah (EMN-RAB) to perform a diagnostic bronchoscopy procedure.
Procedure: Bronchoscopy for peripheral pulmonary lesion biopsy
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Exposure During Study Bronchoscopy
Time Frame: During the bronchoscopy procedure
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.
During the bronchoscopy procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Bronchoscopy
Time Frame: During the bronchoscopy procedure
Duration of bronchoscopy is defined as the time (in minutes) from insertion of the robotic catheter into the endotracheal tube to removal of the catheter from the endotracheal tube after completion of the procedure.
During the bronchoscopy procedure
Need for Additional Diagnostic Procedures
Time Frame: 12 months
This outcome is defined as any additional diagnostic procedure performed to evaluate the lung lesion of interest after the index bronchoscopy. Procedures include repeat bronchoscopy, transthoracic needle biopsy, or surgical lung biopsy.
12 months
Diagnostic Accuracy at 12 Months Post-Bronchoscopy
Time Frame: 12 months
Diagnostic accuracy is defined as the ability of the index bronchoscopy procedure to correctly identify the pathology of the target lung nodule, as confirmed by clinical follow-up, additional diagnostic procedures, or surgical pathology within 12 months after the biopsy. Both malignant and specific benign diagnoses will be included in the assessment of accuracy.
12 months
Specimen Suitability for Molecular Analysis
Time Frame: Baseline and 1 year
This outcome assesses whether tissue obtained during the index bronchoscopy procedure is adequate for molecular analysis when clinically indicated. Specimen suitability will be determined based on quantity, quality, and integrity of the tissue for intended molecular testing.
Baseline and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Rush University Medical Center

Investigators

  • Principal Investigator: See-Wei Low, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.

IPD Sharing Time Frame

The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.

IPD Sharing Access Criteria

Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Cleveland Clinic Institutional Review Board and the study executive committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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