- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02582944
Electromagnetic Navigation for Peripheral Pulmonary Lesions
December 21, 2017 updated by: Washington University School of Medicine
Electromagnetic Navigation for Peripheral Pulmonary Lesions Using a Tip Tracked Steerable Catheter and Optical Guidance
Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed.
The potential advantages of catheter based techniques include the ability to utilize instruments smaller than the diameter of a conventional bronchoscope, thereby allowing better access to the lung periphery.
The drawbacks of a catheter based approach include the relative inability to steer a conventional catheter, and the inability to perform direct visualization and airway inspection through a conventional catheter.
This study will evaluate a novel steerable catheter system with optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy peripheral pulmonary lesions.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 62864
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with peripheral lung lesions 1-7cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
- Are at least 18 years old
- Are able to provide informed consent
Exclusion Criteria:
- Patients who refuse to participate
- Are less than 18 years of age
- Are pregnant
- Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
- Are unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1: Electromagnetic navigation
|
-Standard of care
-Electromagnetic navigation
-Endobronchial ultrasound mini-probe
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic yield of peripheral bronchoscopy using the tip tracked steerable catheter with removable optics and electromagnetic navigation guidance
Time Frame: At the time of procedure (1 day)
|
-Primary outcome of diagnostic yield based on final cytology and/or histopathology will be determined from the results of the bronchoscopy.
A biopsy that results in a specific diagnosis, either malignant or benign, that adequately explains the clinical scenario as determined by the treating physician, will be considered truly positive.
|
At the time of procedure (1 day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmation of successful navigation by using radial probe endobronchial ultrasound
Time Frame: At the time of procedure (1 day)
|
At the time of procedure (1 day)
|
|
Safety as measured by adverse event rates
Time Frame: At the time of procedure (1 day)
|
-Pneumothorax will be documented by post-biopsy CXR or chest ultrasonography, and the number requiring intervention, such as chest tube placement, will be recorded.
Significant hemoptysis will be defined as bleeding noted at the time of procedure that requires a change in the level of care (e.g.
outpatient to inpatient or inpatient to ICU) or a blood transfusion.
Other adverse events that are common to bronchoscopy will be monitored
|
At the time of procedure (1 day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alexander Chen, M.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2015
Primary Completion (Actual)
May 19, 2017
Study Completion (Actual)
May 19, 2017
Study Registration Dates
First Submitted
October 20, 2015
First Submitted That Met QC Criteria
October 20, 2015
First Posted (Estimate)
October 21, 2015
Study Record Updates
Last Update Posted (Actual)
December 26, 2017
Last Update Submitted That Met QC Criteria
December 21, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 201502080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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