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

Lung Lesion(s) Requiring Evaluation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410837
• Other study ID #: COVENBP0475
• Status: Completed
• Start date: April 16, 2015
• Est. completion date: November 1, 2019

Study information

• Verified date: May 2021
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1388
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Lung Lesion(s) Requiring Evaluation

Intervention

Procedure:
• Electromagnetic Navigation Bronchoscopy

Locations

Country	Name	City	State
Austria	AKH Linz	Linz
Austria	Salzburger Landesklinik (SALK)	Salzburg
Denmark	Rigshospitalet - Copenhagen	Kobenhavn
France	University Hospitals of Saint Etienne France	St. Etienne
Italy	Azienda Ospedaliero Universitaria Careggi	Firenze
Italy	IRCCS Azienda Ospedaliera Universitaria San Martino - IST	Genova
Spain	Hospital Fundacion Jimenez Diaz	Madrid
United Kingdom	St. Bartholomew's Hospital	London
United States	University of Michigan Health Systems	Ann Arbor	Michigan
United States	Seton Medical Center Austin	Austin	Texas
United States	Pulmonary and Critical Care Associates of Baltimore	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Pulmonary and Sleep of Tampa Bay	Brandon	Florida
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Carolina's Healthcare System	Charlotte	North Carolina
United States	Pulmonary Medicine Center of Chattanooga - Memorial Health	Chattanooga	Tennessee
United States	The University of Chicago	Chicago	Illinois
United States	University of Cincinnati Physicians Company LLC	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals of Case Medical Center	Cleveland	Ohio
United States	Penn Highlands Healthcare	DuBois	Pennsylvania
United States	Duke University	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	East Carolina University	Greenville	North Carolina
United States	Gundersen Lutheran Medical Foundation, Inc	La Crosse	Wisconsin
United States	Virtua Medical Group, PA	Marlton	New Jersey
United States	Blount Memorial Hospital	Maryville	Tennessee
United States	Pulmonary Associates of Mobile, P.C.	Mobile	Alabama
United States	Palo Alto Medical Foundation	Mountain View	California
United States	Vanderbilt University	Nashville	Tennessee
United States	Cancer Treatment Centers of America	Newnan	Georgia
United States	Ocala Lung and Critical Care	Ocala	Florida
United States	Pinehurst Medical Center	Pinehurst	North Carolina
United States	UPMC - Shadyside Medical Center	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	East Texas Medical Center	Tyler	Texas
United States	Providence Health Center	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Austria,  Denmark,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Pneumothorax (All)	The incidence of pneumothorax related to all ENB™ index procedures will be evaluated.	index procedure visit
Secondary	Incidence of Bronchopulmonary Hemorrhage	The incidence of bronchopulmonary hemorrhage (rated as Grade 2 or higher according to th CTCAE scale) related to all ENB™ index procedures will be evaluated.; Bronchopulmonary hemorrhage is a disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.; Severity increases as grade increases. Grade 1: Mild symptoms; intervention not indicated; Grade 2: Moderate symptoms; medical intervention indicated; Grade 3: Transfusion, radiologic, endoscopic, or operative intervention indicated (e.g., hemostasis of bleeding site); Grade 4: Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated; Grade 5: Death	index procedure visit
Secondary	Incidence of Respiratory Failure	The incidence of respiratory failure (rated as Grade 4 or higher according to the CTCAE scale) related to all ENB™ index procedures will be evaluated.; A respiratory failure is a disorder characterized by impaired gas exchange by the respiratory system resulting in hypoxemia and a decrease in oxygenation of the tissues that may be associated with an increase in arterial levels of carbon dioxide.; Severity increases as grade increases. Within CTCAE, there are no grades 1, 2, or 3 for Respiratory Failure.; Grade 4: Life-threatening consequences; urgent intervention, intubation, or ventilatory support indicated; Grade 5: Death	index procedure visit
Secondary	Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State)	Subject health status evaluated by EuroQol-5d (EQ-5D) questionnaire at all visits. (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health state) Questionnaire from EuroQol Group. Outcome reported on overall health state over time. 0 = worst imaginable health state, 100 = best imaginable health state.	Baseline, 1 month, 12 month, and 24 month follow up visits
Secondary	Subject Satisfaction	Subject satisfaction evaluation at the 1 month visit.; The question was "overall, how satisfied were you with the ENB procedure". Options were: Totally Dissatisfied; Dissatisfied; Neutral; Satisfied; Extremely Satisfied	at the 1 month follow up visit
Secondary	Subject Productivity and Activity	Electromagnetic Navigation Bronchoscopy (ENB) procedure effect on subject productivity and activity using the ENB Productivity and Activity Questionnaire (ENB-PAQ) will be evaluated.; The outcome measurement is the effect of ENB on their regular daily activities on a scale of 0-10 (0=no effect, 10=completely prevented).	at the 1 month follow up visit
Secondary	Diagnostic Yield	Diagnostic yield will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other lung diseases in a lung lesion.; Diagnostic yield was calculated per subject as the rate of true positives (TP) (for malignancy) plus true negatives (TN) (for malignancy) out of all subjects with attempted lung lesion biopsies (the denominator included subjects with no tissue obtained due to unsuccessful navigation).	up to 24 months
Secondary	Sensitivity	Sensitivity will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other lung diseases in a lung lesion. [True Positives =TP, False Negatives = FN].; (TP / [TP+FN])	up to 24 months
Secondary	Specificity	Specificity will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. [True Negatives = TN, False Positives = FN] (TN / [FP+TN])	up to 24 months
Secondary	Positive Predictive Value	Positive predictive value (PPV) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. [True Positives = TP, False Positives = FP] (TP / [TP+FP])	up to 24 months
Secondary	Negative Predictive Value	Negative Predictive Value (NPV) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. [True Negatives = TN, False Negatives = FN] (TN / [FN+TN])	up to 24 months
Secondary	Repeat Biopsy Rate	Repeat biopsy rate due to lack of diagnosis during the ENB™ index procedure will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion.	up to 24 months
Secondary	Tissue Adequacy for Molecular Genetic Testing	Tissue adequacy for molecular genetic testing (if applicable).	at index procedure visit
Secondary	Diagnosis	Diagnosis will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion (per subject)	up to 24 months
Secondary	Stage at Diagnosis	Stage at diagnosis (if applicable) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. (Diagnosis worsens as stage number increases).; Refer to the American Joint Committee on Cancer, 7th edition on Lung Cancer Staging. A brief description is provided here.; Stage I = small lesions, no lymph node involvement Stage II = larger lesions and/or lymph nodes on sides of lung involved Stage III = larger lesions and/or lymph nodes in middle of chest involved Stage IV = metastases to other organs	up to 24 months
Secondary	Success Rate of Accurate Placement of Fiducial Markers	The success rate of accurate placement of fiducial markers demonstrated through follow up imaging will be evaluated for all ENB™ index procedures conducted for placement of fiducial markers.	at index procedure visit
Secondary	Success Rate of Dye Marking	The success rate of dye marking demonstrated by successful surgical resection will be evaluated for all ENB™ index procedures conducted for dye marking in preparation for surgical resection.	at index procedure visit
Secondary	Success Rate of Obtaining Lymph Node Biopsy	The success rate of obtaining a lymph node biopsy to provide the stage of diagnosis will be evaluated for all ENB™ index procedures conducted for a lymph node biopsy.	at index procedure visit