superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2019-02-18

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fluoroscopic Navigation Arm

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.

Group Type EXPERIMENTAL

superDimension™ Navigation System Version 7.2

Intervention Type DEVICE

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

Interventions

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superDimension™ Navigation System Version 7.2

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No