Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices (ALOSPNDY)
Primary Purpose
Pulmonary Coin Lesion
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lung biopsy using Always On EM Tip Tracked Device
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Coin Lesion focused on measuring diagnostic yield, Electromagnetic Tip Tracked, peripheral lung lesion
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients recommended for a lung biopsy.
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01389154
First Posted
July 1, 2011
Last Updated
July 16, 2014
Sponsor
Veran Medical Technologies
Collaborators
Institute for Quality Resource Management
1. Study Identification
Unique Protocol Identification Number
NCT01389154
Brief Title
Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices
Acronym
ALOSPNDY
Official Title
A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Product Enhancements completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veran Medical Technologies
Collaborators
Institute for Quality Resource Management
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Coin Lesion
Keywords
diagnostic yield, Electromagnetic Tip Tracked, peripheral lung lesion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients recommended for a lung biopsy.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lung biopsy using Always On EM Tip Tracked Device
Other Intervention Name(s)
Always On Electromagnetic Tip Tracked Diagnostic Yield
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm.
Description
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.
Time Frame
Within 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momen Wahidi, MD, MBA
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
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Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices
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