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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
The Cleveland Clinic
Study ID
NCT07411989
Status
Not Yet Recruiting

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Conditions

  • Lung Nodules
  • Peripheral Pulmonary Lesions (PPLs)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Dec 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
346 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Ion™ Endoluminal System (shape sensing RAB)
    Providers will utilize the Ion™ Endoluminal System (shape sensing RAB) to perform a diagnostic bronchoscopy procedure.
  • Active Comparator: Galaxy by Noah (EMN-RAB)
    Providers will utilize the Galaxy by Noah (EMN-RAB) to perform a diagnostic bronchoscopy procedure.

Primary Outcome Measure

Diagnostic yield [ Time Frame: 7 days post enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-
The Cleveland ClinicClevelandOhio44195
See-Wei Low, MD
[email protected]
216-445-0570
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 (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Rush University Medical Center· Chicago, ILThe Cleveland Clinic· Cleveland, OH

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