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NCT06676956 · ClinicalTrials.gov registry record · NA

The SEQUENCE Trial: Evaluating Diagnostic Yield of Robotic-assisted Bronchoscopy When Staging EBUS is Performed First or Second in the Same Procedure

A NA study of Pulmonary Nodules, sponsored by Northwestern University.

Recruiting
Registry status
NA
Development phase
320
Enrollment target
1
Study location

NCT06676956 is a NA study of Pulmonary Nodules that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 320 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT06676956, a NA study of Pulmonary Nodules, is actively recruiting participants, sponsored by Northwestern University.

RECRUITING
Registry status
NA
Development phase
320 participants
Enrollment target
1
Study location

Study Summary

Robotic-assisted bronchoscopy (RaB) has afforded proceduralists the ability to accurately reach the periphery of the lung for biopsy of pulmonary nodules1. This has paved the way for patients to undergo both biopsy of a peripheral nodule and a staging linear endobronchial ultrasound (EBUS) in the same anesthesia event, promoting quicker throughput from discovery of a lesion to guideline-adherent treatment2. Further, introduction and mainstream utilization of cone-beam CT (CBCT) has provided the bronchoscopist the ability to refine needle position with tool-in-lesion confirmation3. While there are no randomized clinical trials promoting efficacy of RaB and CBCT in comparison with other bronchoscopic methods, in single center retrospective studies, diagnostic yield has consistently proven to be in the 70-85% range, superior to prior technologies4-6. One of the limitations of utilization of RaB and CBCT is the detrimental effect that atelectasis plays in the bronchoscopy procedure. This can lead to false positive radial EBUS (rEBUS) signals and non-diagnostic procedures7. This incidence of atelectasis has been evaluated prospectively, using a protocol featuring 8-10 cmH2O of PEEP and limiting hyperoxia8, and results suggest this ventilator strategy does an adequate job preventing intraprocedural lung collapse. However, this study only evaluated incidence of atelectasis and did not elaborate on its impact on diagnostic yield. Further unknown is the optimal sequence of performance of RaB and a staging linear EBUS in patients with a radiographically normal mediastinum. Starting with either the RaB or Linear EBUS both have their pros and cons. The benefit to performance of a linear EBUS first is the potential to obviate the need for peripheral nodule biopsy by obtaining rapid, on-site pathologic feedback of occult nodal disease, reducing some of the risk of the procedure (i.e. bleeding and pneumothorax).6 Conversely, the pitfalls to performing linear EBUS first is the po

Conditions Studied

Interventions

  • PROCEDURE Order of bronchoscopy procedures for peripheral nodule biopsy

Study Locations (1)

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2024-11-10
Est. Completion 2027-04-01
Phase NA

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT06676956

The ClinicalTrials.gov registry entry for NCT06676956 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Nodules appearing as the primary indexed condition, and to 1 intervention - of which Order of bronchoscopy procedures for peripheral nodule biopsy is the first listed.

NCT06676956 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT06676956 about?

NCT06676956 is a clinical study titled "The SEQUENCE Trial: Evaluating Diagnostic Yield of Robotic-assisted Bronchoscopy When Staging EBUS is Performed First or Second in the Same Procedure". Robotic-assisted bronchoscopy (RaB) has afforded proceduralists the ability to accurately reach the periphery of the lung for biopsy of pulmonary nodules1. This has paved the way for patients to undergo both biopsy of a peripheral nodule and a staging linear endobronchial ultrasound (EBUS) in the sa...

What is the current status of trial NCT06676956?

This trial is currently recruiting. It is a NA study. The enrollment target is 320 participants. The study started on 2024-11-10. Estimated completion is 2027-04-01.

What conditions does trial NCT06676956 study?

This clinical trial studies the following conditions: Pulmonary Nodules.

What interventions are being tested in trial NCT06676956?

The interventions under investigation include: Order of bronchoscopy procedures for peripheral nodule biopsy (PROCEDURE).

Who is sponsoring clinical trial NCT06676956?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06676956 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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