Health TrialsbyHealthPanel

The SEQUENCE Trial

ConditionPulmonary Nodules
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Peripheral Pulmonary Nodule undergoing a robotic-assisted bronchoscopy

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Linear EBUS first

    Diagnostic test

    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

    Diagnostic test

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

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Linear EBUS FirstActive comparator 1 intervention
Group B: Robotic-assisted bronchoscopy firstActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who received a diagnosis as a result of the procedure

This will be an outcome measure that is positive or negative based on whether a diagnosis was achieved during 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

Secondary outcomes

1

Severity of atelectasis during the procedure

Using the IPOG atelectasis score (mild, moderate, and severe) we will track the impact atelectasis has on the biopsy and diagnostic yield

Time frame
This will be assessed day of procedure and recorded

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Johns Hopkins University

Collaborator

University of Michigan

Collaborator

University of North Carolina, Chapel Hill

Collaborator

University of California, Davis

Collaborator

University of California, San Diego

Collaborator

Source ClinicalTrials.gov
Apply now