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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: Recruiting NA study of Pulmonary Nodules, sponsored by Northwestern University.
NCT06676956 is a NA study of Pulmonary Nodules that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 320 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
This will be an outcome measure that is positive or negative based on whether a diagnosis was achieved during the procedure
Conditions Studied
Interventions
- PROCEDURE Order of bronchoscopy procedures for peripheral nodule biopsy
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2024-11-10 |
| Est. Completion | 2027-04-01 |
| Phase | NA |
What NCT06676956 shows while recruiting
NCT06676956 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06676956's enrollment target sits among peer trials
320 315th of 2000 higher than 1,680 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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