Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy

NCT02109458 | Completed Results

• 1 other identifier: NA_00086035
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Pulmonary Nodules

Keywords

Lung nodule biopsy

Outcome Measures

Primary Outcomes (2)

• Feasibility

  Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)

  Immediately following procedure

• Incidence of Pneumothorax

  Presence of pneumothorax assessed in participants with successful completion of biopsy.

  Immediately after procedure

Secondary Outcomes (2)

• Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone

  Approximately 1 week upon receipt of pathology report

• Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB

  Approximately 1 week upon receipt of pathology report

Study Arms (1)

Assessing peripheral pulmonary nodules

EXPERIMENTAL

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).

Device: Navigation guided bronchoscopy

Interventions

Navigation guided bronchoscopy DEVICE

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

Assessing peripheral pulmonary nodules

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Veran Medical Technologies: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Results Point of Contact

• Title: Dr. Lonny Yarmus
• Organization: Johns Hopkins University School of Medicine

lyarmus@jhmi.edu

4105025224

Study Officials

• Lonny Yarmus, DO

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: April 10, 2014
• Study Start: September 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 24, 2017
• Results First Posted: April 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)