Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices

Study Overview
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Brief Summary
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The objective of the prospective, multi-center study is to evaluate the ease of use and effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and beyond the bronchus. Measures of diagnostic yield will be compared to the diagnostic yield of similar published historical controls using conventional bronchoscopy.

Detailed Description
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Always On EM Tip Tracked Steerable catheters and biopsy devices used with the Veran Medical Technologies system are Food and Durg Administration 510K approved for use in diagnostic pulmonary procedures to locate and sample subsegmental peripheral, less than 3.0 centimeter lung lesions or solitary pulmonary nodules(SPN). Up to 20 subjects with radiographically confirmed peripheral lung lesions will be asked to participate in the study and proceed with informed consent. An interim analysis of the data will be conducted to determine the need to include an additional 10 patients to achieve statistically significant results at the ninety five percent confidence interval.

Official Title
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A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy

Conditions
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Pulmonary Coin Lesion

Intervention / Treatment
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* Procedure: Lung biopsy using Always On EM Tip Tracked Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject provides informed consent Subject is older than 50 years of age with 50% of patients at least 65 years of age Patient has a minimum of 20 pack years Subject scheduled to undergo conventional bronchoscopy as part of their standard medical care Subject has radiographically confirmed sub-segmental peripheral < 3.0 cm lung lesions A negative pregnancy test in women of child-bearing potential Subject is willing and able to return for all required follow-up Subject is mentally capable of following study directions Exclusion Criteria: Subject has pacemaker, implantable cardioverter, and/or defibrillator Subject has any disease or condition that interferes with safe completion of initial or follow-up assessments Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy prior to their enrollment in this study Concurrent participation in another study involving investigational drugs or investigational medical devices Inability to read and understand the necessary study documents

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients recommended for a lung biopsy.<br>Patients with a positive diagnosis of a peripheral, less than 3.0 centimeter lung lesion, recommended for bronchoscopic biopsy are eligible to be consented into the study. | Procedure: Lung biopsy using Always On EM Tip Tracked Device<br>* Patients screened by CT to have a subsegmental, less than 3.0 centimeter lung lesion will be assigned to outpatient bronchoscopy. The patient will have a chest CT with the Always on Patient vPad. Access to the lesion will be achieved using Electromagnetic Tip Tracked devices. Once accessed the operator will use the Electromagnetic Tip Tracked devices or standard devices to obtain a biopsy sample to then be to pathology for diagnosis and reporting. Once completed the patient will be moved to recovery and discharged. If the biopsy is negative the patient will be advised by the pulmonologist about other interventions, watchful waiting, or no further treatment. If the biopsy is positive, the patient will be referred to their physician for further treatment.<br>* Other names: Always On Electromagnetic Tip Tracked Diagnostic Yield;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm. | Biopsy samples will be sent to the lab for analysis of the presence, absence, or identification of an occult particulate taken from the patient's lung. Patients with a negative biopsy result will be followed if recommended for another intervention and if recommended to watchful waiting. Follow up outcomes will be included in the outcome measures. | Within 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostic yield, Electromagnetic Tip Tracked, peripheral lung lesion