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

NCT07411989 | Not Yet Recruiting

• 1 other identifier: 26-119
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 2

Brief 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 bronchoscopy with integrated cone beam CT (Ion™ Endoluminal System by Intuitive) in patients undergoing bronchoscopy for peripheral pulmonary lesion (PPL) evaluation.

Conditions

Peripheral Pulmonary Lesions (PPLs); Lung Nodules

Keywords

Bronchoscopy; Peripheral Pulmonary Lesions; Robotic assisted bronchoscopy; Lung biopsy

Outcome Measures

Primary Outcomes (1)

• 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: 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 Outcomes (1)

• Radiation Exposure During Study Bronchoscopy

  During the bronchoscopy procedure

Other Outcomes (4)

• Duration of Bronchoscopy

  During the bronchoscopy procedure

• Need for Additional Diagnostic Procedures

  12 months

• Diagnostic Accuracy at 12 Months Post-Bronchoscopy

  12 months

Study Arms (2)

Ion™ Endoluminal System (shape sensing RAB)

ACTIVE COMPARATOR

Providers will utilize the Ion™ Endoluminal System (shape sensing RAB) to perform a diagnostic bronchoscopy procedure.

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.

Procedure: Bronchoscopy for peripheral pulmonary lesion biopsy

Interventions

Bronchoscopy for peripheral pulmonary lesion biopsy PROCEDURE

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).

Galaxy by Noah (EMN-RAB); Ion™ Endoluminal System (shape sensing RAB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age at time of bronchoscopy
• Scheduled for navigational bronchoscopy for the evaluation of pulmonary lesion

You may not qualify if:

• \. Inability to provide informed consent

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Rush University Medical Center: collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (19)

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MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• See-Wei Low, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

See-Wei Low, MD

CONTACT

216 445-0570; LOWS5@ccf.org

Yvonne Meli, RN

CONTACT

216 445-4215; MELIY@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: It is not possible to blind the bronchoscopist or the patient to the platform used for each procedure, as they are both large distinctive-appearing pieces of equipment. However, thoracic pathologists (the outcomes assessor) and bronchoscopy schedulers (the care provider team) will remain blinded, such that allocations should be unable to influence their histopathological interpretation or scheduling of procedures in a given bronchoscopy suite, respectively.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Pulmonologist

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
• 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.

Locations

US (2)