Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy

NCT ID: NCT02109458

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-08-31

Brief Summary

The goal of this study is to evaluate the feasibility and safety of navigation guided virtual transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of peripheral pulmonary nodules (PPN).

Detailed Description

Accessing peripheral pulmonary nodules is problematic because they are often not visible endobronchially, not large enough to be visualized by x-ray fluoroscopy for transbronchial biopsy (TBBx), and/or do not lie within an accessible airway. In this study, investigators hope to evaluate new technologies to aid in PPN biopsy using navigation bronchoscopy (NB) combined with navigation transthoracic needle aspiration (N-TTNA) sampling of a PPN.

Patients meeting inclusion criteria who consent will undergo a convex Endobronchial Ultrasound (EBUS) bronchoscopy for evaluation and sampling of the mediastinum and hilum. Following this, NB will be performed with an ultrathin bronchoscope (4mm outer diameter with a 2 mm working channel) with R-EBUS and fluoroscopy. If the lesion is localized by NB and/or radial EBUS in conjunction with NB, TBBX will be taken. At the conclusion of TBBX sampling, a fluoroscopic evaluation to assess for the presence of pneumothorax will be performed and if one is present, appropriate clinical measures will be taken at the discretion of the treating team (tube thoracostomy, observation, etc.) and no further sampling techniques will be utilized. If the lesion was not able to be localized via NB and/or the physician feels insufficient sample was acquired for diagnosis and there is no evidence of pneumothorax, the patient will undergo N-TTNA at the same PPN during the same procedure time. It is envisioned that between 8-12 patients will require a N-TTNA to complete diagnosis.

Conditions

Peripheral Pulmonary Nodules

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Assessing peripheral pulmonary nodules

To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).

Group Type: EXPERIMENTAL

Navigation guided bronchoscopy

Intervention Type: DEVICE

Navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB); guidance system is by Veran Medical Technologies, Inc.

Interventions

Navigation guided bronchoscopy

Navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB); guidance system is by Veran Medical Technologies, Inc.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Target patient population: Patients with a peripheral pulmonary nodule as identified on CT chest ≤3cm from the pleura will be recruited. A PPN will be defined as a lesion >10mm and <3cm in diameter surrounded by lung parenchyma on CT chest. The decision for biopsy of the PPN will be made by the treating physician and agreed upon by the patient.
• Participants must be at least 18 years old or older
• No bleeding disorders
• Provide informed consent.

Exclusion Criteria

• less than 18 years
• lack of fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
• inability to give informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veran Medical Technologies

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lonny Yarmus, DO

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00086035

Identifier Type: -

Identifier Source: org_study_id