NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

NCT02410837 | Completed Results

• 1 other identifier: COVENBP0475
• Study Type: observational
• Target: 1,388
• Locations: 7 countries
• Sites: 37

Brief Summary

The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.

Conditions

Lung Lesion(s) Requiring Evaluation

Keywords

lung lesion; biopsy; bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Incidence of Pneumothorax (Grade 2+)

  The primary endpoint is the incidence of pneumothorax related to the ENB™ index procedure rated as Grade 2 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE) scale. Pneumothorax is a disorder characterized by abnormal presence of air in the pleural cavity resulting in the collapse of the lung. Severity increases as grade increases. Grade 1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated; Grade 2: Symptomatic; intervention indicated (e.g., tube placement without sclerosis); Grade 3: Sclerosis and/or operative intervention indicated; hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death

  index procedure visit

Secondary Outcomes (18)

• Incidence of Pneumothorax (All)

  index procedure visit

• Incidence of Bronchopulmonary Hemorrhage

  index procedure visit

• Incidence of Respiratory Failure

  index procedure visit

• Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State)

  Baseline, 1 month, 12 month, and 24 month follow up visits

• Subject Satisfaction

  at the 1 month follow up visit

Interventions

Electromagnetic Navigation Bronchoscopy PROCEDURE

Also known as: ENB, superDimension

Eligibility Criteria

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

Study Population

Subjects that meet the various inclusion/exclusion criteria will be enrolled consecutively by each participating site.

You may qualify if:

• Subject presents with lung lesion(s) requiring evaluation
• Subject is willing and able to provide informed consent to participate in the study
• Subject is candidate for elective ENB™ procedure
• Subject is over the age of 18

You may not qualify if:

• The subject is unable or unwilling to comply with study follow-up schedule
• The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
• Female subjects who are pregnant or nursing as determined by standard site practices

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (37)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, 35294, United States

Location

Palo Alto Medical Foundation

Mountain View, California, 94040, United States

Location

Pulmonary and Sleep of Tampa Bay

Brandon, Florida, 33511, United States

Location

Ocala Lung and Critical Care

Ocala, Florida, 34471, United States

Location

Cancer Treatment Centers of America

Newnan, Georgia, 30265, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Pulmonary and Critical Care Associates of Baltimore

Baltimore, Maryland, 21237, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Virtua Medical Group, PA

Marlton, New Jersey, 08053, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

Carolina's Healthcare System

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Pinehurst Medical Center

Pinehurst, North Carolina, 28374, United States

Location

University of Cincinnati Physicians Company LLC

Cincinnati, Ohio, 45206, United States

Location

University Hospitals of Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Penn Highlands Healthcare

DuBois, Pennsylvania, 15801, United States

Location

UPMC - Shadyside Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Pulmonary Medicine Center of Chattanooga - Memorial Health

Chattanooga, Tennessee, 37404, United States

Location

Blount Memorial Hospital

Maryville, Tennessee, 37804, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Seton Medical Center Austin

Austin, Texas, 78701, United States

Location

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

Providence Health Center

Waco, Texas, 76712, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Gundersen Lutheran Medical Foundation, Inc

La Crosse, Wisconsin, 54601, United States

Location

AKH Linz

Linz, 4020, Austria

Location

Salzburger Landesklinik (SALK)

Salzburg, Austria

Location

Rigshospitalet - Copenhagen

Copenhagen, Denmark

Location

University Hospitals of Saint Etienne France

Saint-Etienne, France

Location

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Location

IRCCS Azienda Ospedaliera Universitaria San Martino - IST

Genova, 16132, Italy

Location

Hospital Fundacion Jimenez Diaz

Madrid, Spain

Location

St. Bartholomew's Hospital

London, United Kingdom

Location

Related Publications (3)

• Bowling MR, Folch EE, Khandhar SJ, Kazakov J, Krimsky WS, LeMense GP, Linden PA, Murillo BA, Nead MA, Pritchett MA, Teba CV, Towe CW, Williams T, Anciano CJ. Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619841234. doi: 10.1177/1753466619841234.

  PMID: 30958102 DERIVED

• Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, Minnich DJ, Murgu SD, Pritchett M, Toloza EM, Wahidi MM, Wolvers JJ, Folch EE; NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59. doi: 10.1186/s12890-017-0403-9.

  PMID: 28399830 DERIVED

• Folch EE, Bowling MR, Gildea TR, Hood KL, Murgu SD, Toloza EM, Wahidi MM, Williams T, Khandhar SJ. Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulm Med. 2016 Apr 26;16(1):60. doi: 10.1186/s12890-016-0228-y.

  PMID: 27113209 DERIVED

Results Point of Contact

• Title: Jennifer Wolvers
• Organization: Medtronic

Jennifer.Wolvers@Medtronic.com

763-258-9405

Study Officials

• Sandeep Khandhar, MD

  Inova Fairfax Hospital

  PRINCIPAL INVESTIGATOR

• Erik Folch, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 8, 2015
• Study Start: April 16, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: May 10, 2021
• Results First Posted: March 11, 2021

Record last verified: 2021-05

Locations

US (29); DK (1); ES (1); GB (1); IT (2); AU (2); FR (1)