Peripheral Lung LesionsPhase 1NCT02582944
Electromagnetic Navigation for Peripheral Pulmonary Lesions
A Phase 1 study testing Olympus BF-180 bronchoscope (standard adult), Veran Spinview Thoracic Navigation System and Olympus UM-S20-17S in people with Peripheral Lung Lesions, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Lung Lesions
- What is being tested?
- Olympus BF-180 bronchoscope (standard adult), Veran Spinview Thoracic Navigation System and Olympus UM-S20-17S
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2015to 19 May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 62864
About this study
Official title: 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.
- Conditions
- Peripheral Lung Lesions
- Being tested
- Olympus BF-180 bronchoscope (standard adult), Veran Spinview Thoracic Navigation System, Olympus UM-S20-17S, Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus BF-180 bronchoscope (standard adult)Device
-Standard of care
Veran Spinview Thoracic Navigation SystemDevice
-Electromagnetic navigation
Olympus UM-S20-17SDevice
-Endobronchial ultrasound mini-probe
BiopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Electromagnetic navigation | Experimental | * The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed.
* Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree.
* Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation.
* Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles. Receives: Device: Olympus BF-180 bronchoscope (standard adult); Device: Veran Spinview Thoracic Navigation System; Device: Olympus UM-S20-17S; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of peripheral bronchoscopy using the tip tracked steerable catheter with removable optics and electromagnetic navigation guidance
-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.
Measured: At the time of procedure (1 day)
Secondary outcomes (2)
Confirmation of successful navigation by using radial probe endobronchial ultrasound
Measured: At the time of procedure (1 day)
Safety as measured by adverse event rates
-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
Measured: At the time of procedure (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start25 Mar 2015
- Primary completion19 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Lung LesionsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Chen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582944
- Sponsor's protocol ID
- 201502080
- Status last verified
- Dec 2017
- First submitted
- 20 Oct 2015
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Navigation for Peripheral Pulmonary Lesions Using a Tip Tracked Steerable Catheter and Optical Guidance
- ClinicalTrials.gov ID
- NCT02582944
- Acronym / sponsor ID
- 201502080
- Conditions
- Peripheral Lung Lesions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Electromagnetic navigation | Experimental | Device: Olympus BF-180 bronchoscope (standard adult), Device: Veran Spinview Thoracic Navigation System, Device: Olympus UM-S20-17S, Procedure: Biopsy* The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed. * Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree. * Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation. * Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olympus BF-180 bronchoscope (standard adult)-Standard of care | Device | Arm 1: Electromagnetic navigation |
| Veran Spinview Thoracic Navigation System-Electromagnetic navigation | Device | Arm 1: Electromagnetic navigation |
| Olympus UM-S20-17S-Endobronchial ultrasound mini-probe | Device | Arm 1: Electromagnetic navigation |
| Biopsy | Procedure or surgery | Arm 1: Electromagnetic navigation |
Primary outcome
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.
2 secondary outcomes
Confirmation of successful navigation by using radial probe endobronchial ultrasound
Time frame: At the time of procedure (1 day)
Safety as measured by adverse event rates
Time frame: At the time of procedure (1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Peripheral Lung Lesions
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OPTIMISE Lung SABR
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Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary Lesions
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Iriscope for the Diagnosis of Peripheral Pulmonary Lesions: a Multicentre Randomised Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Chen, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olympus BF-180 bronchoscope (standard adult), Veran Spinview Thoracic Navigation System and Olympus UM-S20-17S in people with Peripheral Lung Lesions, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.