Electromagnetic Navigation for Peripheral Pulmonary Lesions

NCT02582944 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 201502080
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Lung Lesions

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of peripheral bronchoscopy using the tip tracked steerable catheter with removable optics and electromagnetic navigation guidance

  -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.

  At the time of procedure (1 day)

Secondary Outcomes (2)

• Confirmation of successful navigation by using radial probe endobronchial ultrasound

  At the time of procedure (1 day)

• Safety as measured by adverse event rates

  At the time of procedure (1 day)

Study Arms (1)

Arm 1: Electromagnetic navigation

EXPERIMENTAL

* The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed. * Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree. * Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation. * Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles.

Device: Olympus BF-180 bronchoscope (standard adult); Device: Veran Spinview Thoracic Navigation System; Device: Olympus UM-S20-17S; Procedure: Biopsy

Interventions

Olympus BF-180 bronchoscope (standard adult) DEVICE

-Standard of care

Arm 1: Electromagnetic navigation

Veran Spinview Thoracic Navigation System DEVICE

-Electromagnetic navigation

Arm 1: Electromagnetic navigation

Olympus UM-S20-17S DEVICE

-Endobronchial ultrasound mini-probe

Arm 1: Electromagnetic navigation

Biopsy PROCEDURE

Arm 1: Electromagnetic navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with peripheral lung lesions 1-7cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
• Are at least 18 years old
• Are able to provide informed consent

You may not qualify if:

• Patients who refuse to participate
• Are less than 18 years of age
• Are pregnant
• Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
• Are unable to provide informed consent

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 62864, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alexander Chen, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Study Start: March 25, 2015
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)