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NCT02582944 · ClinicalTrials.gov registry record · Phase 1

Electromagnetic Navigation for Peripheral Pulmonary Lesions

A Phase 1 study, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target

NCT02582944: Completed Phase 1 study, sponsored by Washington University School of Medicine.

NCT02582944 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02582944, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. The potential advantages of catheter based techniques include the ability to utilize instruments smaller than the diameter of a conventional bronchoscope, thereby allowing better access to the lung periphery. The drawbacks of a catheter based approach include the relative inability to steer a conventional catheter, and the inability to perform direct visualization and airway inspection through a conventional catheter. This study will evaluate a novel steerable catheter system with optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy peripheral pulmonary lesions.

Primary Outcome

-Primary outcome of diagnostic yield based on final cytology and/or histopathology will be determined from the results of the bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, that adequately explains the clinical scenario as determined by the treating physician, will be considered truly positive.

Interventions

  • PROCEDURE Biopsy
  • DEVICE Olympus BF-180 bronchoscope (standard adult)
  • DEVICE Veran Spinview Thoracic Navigation System
  • DEVICE Olympus UM-S20-17S

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2015-03-25
Est. Completion 2017-05-19
Phase Phase 1

What the finished NCT02582944 record still lists

NCT02582944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 4 interventions - of which Biopsy is the first listed.

NCT02582944 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02582944 about?

NCT02582944 is a clinical study titled "Electromagnetic Navigation for Peripheral Pulmonary Lesions". Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. The potential advantages of catheter based techniques include the ability to utilize instruments smaller than the diameter of a conventional bronchoscope, th...

What is the current status of trial NCT02582944?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2015-03-25. Estimated completion is 2017-05-19.

What interventions are being tested in trial NCT02582944?

The interventions under investigation include: Biopsy (PROCEDURE), Olympus BF-180 bronchoscope (standard adult) (DEVICE), Veran Spinview Thoracic Navigation System (DEVICE), Olympus UM-S20-17S (DEVICE).

Who is sponsoring clinical trial NCT02582944?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02582944's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT02582944, the US trial registry maintained by the National Library of Medicine. NCT02582944 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.