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superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03585959
Recruitment Status : Active, not recruiting
First Posted : July 13, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: superDimension™ Navigation System Version 7.2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: superDimension™ Navigation System 7.2
superDimension™ Navigation System Version 7.2
Device: superDimension™ Navigation System Version 7.2
superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy




Primary Outcome Measures :
  1. Confirm the location accuracy of the local registration feature [ Time Frame: Up to 7 days post procedure ]
    Confirm the location accuracy of the local registration feature of the superDimension™ Navigation System Version 7.2 in subjects undergoing lung lesion biopsy.


Secondary Outcome Measures :
  1. Number of cases that are technically successful (successful completion of local registration) [ Time Frame: Up to 7 days post procedure ]
    In cases that are not technically successful, reason for incomplete local registration in each target lesion.

  2. Investigator confirmation that the catheter is in an "Adequate Periprocedural Location" using the electromagnetic navigation bronchoscopy (ENB) technology. [ Time Frame: Up to 7 days post procedure ]
    Investigator confirmation that the catheter is in an "Adequate Periprocedural Location" using the electromagnetic navigation bronchoscopy (ENB) technology.


Other Outcome Measures:
  1. Total Procedure Time [ Time Frame: Up to 7 days post procedure ]
    Total procedure time captured in the electronic data capture database being utilized for the study.

  2. ENB Procedure Time [ Time Frame: Up to 7 days post procedure ]
    ENB procedure time captured in the electronic data capture database being utilized for the study.

  3. Total fluoroscopy time, as measured by the fluoroscopy system [ Time Frame: Up to 7 days post procedure ]
    Total fluoroscopy time captured in the electronic data capture database being utilized for the study.

  4. Adequacy of the ENB-aided tissue sample [ Time Frame: Up to 7 days post procedure ]
    Adequacy of the ENB-aided tissue sample for rapid on-site evaluation (ROSE) of cytologic samples by pathology (when applicable). This will be captured in the electronic data capture database.

  5. Histopathological call based on ROSE of the ENB-aided tissue sample (when applicable) [ Time Frame: Up to 7 days post procedure ]
    Histopathological call based on ROSE of the ENB-aided tissue sample (when applicable) captured in the electronic data capture database being utilized for the study.

  6. Final pathology results of the ENB-aided tissue sample [ Time Frame: Up to 7 days post procedure ]
    Final pathology results of the ENB-aided tissue sample captured in the electronic data capture database being utilized for the study.

  7. Biopsy tools used, tool order, number of passes, and diagnoses for each tool based on ROSE and final pathology of the ENB-aided sample [ Time Frame: Up to 7 days post procedure ]
    Biopsy tools used, tool order, number of passes, and diagnoses for each tool based on ROSE and final pathology of the ENB-aided sample, captured in the electronic data capture database being utilized for the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject presents with lung lesion(s) greater than 10 mm 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 not 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585959


Locations
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United States, North Carolina
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Michael A. Pritchett, DO MPH FirstHealth Moore Regional Hospital
Principal Investigator: Krishnendu Bhadra, MD CHI Memorial Medical Group

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03585959     History of Changes
Other Study ID Numbers: MDT18004ILSFNV
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study will be shared in the form of a Clinical Study Report that will be approved for Publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No