Recruiting

RaB & EBUS

Sponsor:

Northwestern University

Code:

NCT06676956

Conditions

Pulmonary Nodules

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Linear EBUS first

Robotic-assisted bronchoscopy first

Study Details

Brief summary:

This study will randomize participants undergoing a bronchoscopic biopsy of a peripheral pulmonary nodule for their standard of care to receive robotic-assisted bronchoscopy (RaB) and then staging linear endobronchial ultrasounnd (EBUS) OR staging linear EBUS first, followed by RaB. The goal of this study is to set the standard for optimizing the sequence of bronchoscopic procedures in patients at risk for early-stage malignancy.

Conditions

Pulmonary Nodules

Study ID

NCT06676956

Start date

Nov 10, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Peripheral Pulmonary Nodule undergoing a robotic-assisted bronchoscopy

Exclusion Criteria:

  • lymph nodes that are enlarged or PET avid on CT prior to procedure

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Linear EBUS First

Patients will undergo a mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy

active comparator: Robotic-assisted bronchoscopy first

Patients will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second

Interventions

Linear EBUS first

Patients randomized to this arm will undergo a mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy.

Robotic-assisted bronchoscopy first

Patients randomized to this arm will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second

Primary outcome measure

  • Number of participants who received a diagnosis as a result of the procedure [ Time Frame: This will be assessed 30 days after the procedure in a study visit that our teams conduct, it will not include the patient ]

Central Contacts and Locations

Central contacts

Chris Kapp Assistant professor of medicine, MD

312-695-3800christopher.kapp@nm.org

Locations

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Chris Kapp, MD

312-695-3800christopher.kapp@nm.org

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jeffrey Thiboutot

jthibou1@jhmi.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

University of North Carolina, Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

More Information

Sponsor

Northwestern University

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-25.