Clinical trial NCT03585959: superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
Official title: A Post-market Feasibility Study Evaluating Location Accuracy Using the superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology in Subjects Undergoing Lung Lesion Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2018-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.

Detailed description: The primary objective of this post-market feasibility study is to confirm the location accuracy of the local registration feature of the superDimension™ Navigation System Version 7.2 in subjects undergoing lung lesion biopsy.

Eligibility criteria: Inclusion Criteria:

1. Subject presents with lung lesion(s) 10 mm or greater in diameter amenable to evaluation by ENB at the time of evaluation
2. Lesion is intended to be biopsied by the participating investigator
3. Subject is willing and able to provide informed consent to participate in the study
4. Subject is a candidate for an elective ENB procedure
5. Subject is over the age of 18

Exclusion Criteria:

1. Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB
2. Lesions within 10 mm of the diaphragm
3. The subject is unable or unwilling to comply with study follow-up schedule
4. The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
5. Female subjects who are pregnant or nursing as determined by standard site practices

Primary outcomes:
measure: Confirm the Location Accuracy of the Local Registration Feature
timeFrame: day of procedure
Secondary outcomes:
measure: Number of Cases That Are Technically Successful (Successful Completion of Local Registration)
timeFrame: day of procedure
measure: Number of Cases That Are Not Technically Successful (Local Registration Not Complete)
timeFrame: day of procedure
measure: Investigator Confirmation That the Catheter is in an "Adequate Periprocedural Location" Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology.
timeFrame: day of procedure
measure: Total Procedure Time
timeFrame: day of procedure
measure: ENB Procedure Time
timeFrame: day of procedure
measure: Total Fluoroscopy Time
timeFrame: day of procedure
measure: Adequacy of the ENB-aided Tissue Sample
timeFrame: Based on final pathology results of the ENB-aided biopsy sample collected day of procedure
measure: Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable)
timeFrame: day of procedure
measure: Final Pathology Results of the ENB-aided Tissue Sample
timeFrame: Based on final pathology results of the ENB-aided biopsy sample collected day of procedure
measure: Biopsy Tools Used
timeFrame: day of procedure
measure: Tool Order
timeFrame: day of procedure
measure: Number of Tool Pases
timeFrame: day of procedure
measure: Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample
timeFrame: Based on ROSE results of the ENB-aided biopsy sample collected day of procedure
measure: Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample
timeFrame: Based on final pathology results of the ENB-aided sample collected day of procedure
measure: Percentage of Cases in Which the Intended Lesion is Correctly Identified
timeFrame: day of procedure
measure: Relational Accuracy in Cases in Which the Intended Lesion is Targeted
timeFrame: day of procedure
Other outcomes:
Locations:
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Chattanooga
country: United States
facility: CHI Memorial Medical Group
state: Tennessee
Study officials:
affiliation: FirstHealth Moore Regional Hospital
name: Michael A. Pritchett, DO MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: CHI Memorial Medical Group
name: Krishnendu Bhadra, MD
role: PRINCIPAL_INVESTIGATOR
References: