superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

NCT03585959 | Completed Results FDA Device

• 1 other identifier: MDT18004ILSFNV
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Confirm the Location Accuracy of the Local Registration Feature

  The Primary Endpoint is the measured ability of the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology to place the center of the virtual navigation target (green ball) on the intended target lesion as confirmed by cone-beam computed tomography (CBCT). The primary endpoint was evaluated in technically successful cases (those with local registration complete) and calculated as the percentage of cases in which the virtual target was correctly placed to overlap the target lesion, as confirmed by CBCT. The percent overlap was calculated in three dimensions (X, Y, and Z coordinates). Any case with more than 0% overlap was considered a primary endpoint success.

  day of procedure

Secondary Outcomes (16)

• Number of Cases That Are Technically Successful (Successful Completion of Local Registration)

  day of procedure

• Number of Cases That Are Not Technically Successful (Local Registration Not Complete)

  day of procedure

• Investigator Confirmation That the Catheter is in an "Adequate Periprocedural Location" Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology.

  day of procedure

• Total Procedure Time

  day of procedure

• ENB Procedure Time

  day of procedure

Study Arms (1)

Fluoroscopic Navigation Arm

EXPERIMENTAL

An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.

Device: superDimension™ Navigation System Version 7.2

Interventions

superDimension™ Navigation System Version 7.2 DEVICE

superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy

Fluoroscopic Navigation Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB
• Lesions within 10 mm of the diaphragm
• 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 (2)

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

CHI Memorial Medical Group

Chattanooga, Tennessee, 37404, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Katie Bayliss
• Organization: Medtronic

katie.j.bayliss@medtronic.com

(763) 647-5547

Study Officials

• Michael A. Pritchett, DO MPH

  FirstHealth Moore Regional Hospital

  PRINCIPAL INVESTIGATOR

• Krishnendu Bhadra, MD

  CHI Memorial Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 13, 2018
• Study Start: August 3, 2018
• Primary Completion: February 13, 2019
• Study Completion: February 18, 2019
• Last Updated: April 29, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)