All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules

A study testing Veran System in people with Lung Cancer, run by Veran Medical Technologies at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Veran System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 9 sitesUnited States
Study dates: 14 Feb 2018to 1 Dec 2019
Phase: Interventional
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient is ≥21 years old,
The patient has a lung nodule identified on chest CT and is a candidate for elective EMN bronchoscopic evaluation as determined by the treating pulmonologist,
The size of the target nodule, as measured at its greatest diameter, is between 1-3cm,
Staging at the time of enrollment indicates NO/N1 (does not involve lymph nodes or includes involvement in nodes within ipsilateral hilum),
The patient has an intermediate risk of malignancy (5-65% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (>65%) and will be referred for surgical evaluation or stereotactic body radiation therapy (SBRT). Note: If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study,
The patient has a lack of bleeding disorders, and
The patient is willing and able to provide informed consent.

Who cannot join

The patient is pregnant as confirmed by urine or serum pregnancy testing,
The patients has a body mass index (BMI) >40,
There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients with a nodule within SPiNPerc range (i.e. The patient would not go on for a CT guided TTNA), OR There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before SBRT.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Grady Memorial Hospital
Atlanta, Georgia, 30303
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
Medical University of South Carolina Medical Center
Charleston, South Carolina, 29425
Duke University Hospital
Durham, North Carolina, 27710
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Swedish Medical Center
Seattle, Washington, 98122
Washington University Medical Center
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Multicenter, Prospective Trial of ElectromagnetIc Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules

This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.

Read the detailed description

The objectives of this study are to evaluate diagnostic yield following biopsy of peripheral pulmonary nodules as identified on chest computed tomography (CT) utilizing (1) Electromagnetic navigation (EMN) bronchoscopy, and/or (2) EMN-transthoracic needle aspiration (TTNA). Overall diagnostic yield will be evaluated to assess the combination of these approaches.

Conditions: Lung Cancer
Being tested: Veran System
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Veran SystemDevice
Also called Veran SPiN Thoracic Navigation System SPiNPerc Kit
Electromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration

Study groups in NCT03338049
Study group	Role	What they receive
Veran System	Other	Staged biopsy sampling methodology. If lymph node staging is negative, EMN-bronchoscopy will be performed. If EMN-bronchoscopy is negative, EMN-TTNA will be performed Receives: Device: Veran System

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic Yield
Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA
Measured: Up to one year post index procedure

Secondary outcomes (4)

Serious Adverse Events
All device and/or procedure related serious adverse events
Measured: 30 days post index procedure
Adverse Events
Rate of all device and procedure related events
Measured: 30 days post index procedure
Rate of procedure cancellation
Impact of same day CT scan on rate of procedure cancellations due decrease in nodule size
Measured: On procedure day
Procedural Factors
Number of instrument passes, type of instrument, site of biopsy
Measured: Intra-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20181 Dec 2019

First posted9 Nov 2017
Study start14 Feb 2018
Primary completion29 Oct 2019
Study completion1 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
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 N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03338049
Sponsor's protocol ID: VMT AIO 2017
Acronym: AIO
Status last verified: May 2020
First submitted: 25 Oct 2017
Last updated: 19 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Thiboutot J, Pastis NJ, Akulian J, Silvestri GA, Chen A, Wahidi MM, Gilbert CR, Lin CT, Los J, Flenaugh E, Semaan R, Burks AC, Sathyanarayan P, Wu S, Feller-Kopman D, Cheng GZ, Alalawi R, Rahman NM, Maldonado F, Lee HJ, Yarmus L. A Multicenter, Single-Arm, Prospective Trial Assessing the Diagnostic Yield of Electromagnetic Bronchoscopic and Transthoracic Navigation for Peripheral Pulmonary Nodules. Am J Respir Crit Care Med. 2023 Oct 15;208(8):837-845. doi: 10.1164/rccm.202301-0099OC.
PubMed 37582154
Mallow C, Lee H, Oberg C, Thiboutot J, Akulian J, Burks AC, Luna B, Benzaquen S, Batra H, Cardenas-Garcia J, Toth J, Heidecker J, Belanger A, McClune J, Osman U, Lakshminarayanan V, Pastis N, Silvestri G, Chen A, Yarmus L. Safety and diagnostic performance of pulmonologists performing electromagnetic guided percutaneous lung biopsy (SPiNperc). Respirology. 2019 May;24(5):453-458. doi: 10.1111/resp.13471. Epub 2019 Jan 24.
PubMed 30675961
Thiboutot J, Lee HJ, Silvestri GA, Chen A, Wahidi MM, Gilbert CR, Pastis NJ, Los J, Barriere AM, Mallow C, Salwen B, Dinga MJ, Flenaugh EL, Akulian JA, Semaan R, Yarmus LB. Study Design and Rationale: A Multicenter, Prospective Trial of Electromagnetic Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules (ALL IN ONE Trial). Contemp Clin Trials. 2018 Aug;71:88-95. doi: 10.1016/j.cct.2018.06.007. Epub 2018 Jun 7.
PubMed 29885373

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Prospective Trial of ElectromagnetIc Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules
ClinicalTrials.gov ID: NCT03338049
Acronym / sponsor ID: AIO / VMT AIO 2017
Conditions: Lung Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Veran Medical TechnologiesIndustry (pharma, biotech, devices)
Study start: 14 Feb 2018 (actual)
Primary completion: 29 Oct 2019 (actual)
Study completion: 1 Dec 2019 (actual)
First posted: 9 Nov 2017 (actual)
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.

This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Veran System	Other	Device: Veran SystemStaged biopsy sampling methodology. If lymph node staging is negative, EMN-bronchoscopy will be performed. If EMN-bronchoscopy is negative, EMN-TTNA will be performed

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

The patient is ≥21 years old,
The patient has a lung nodule identified on chest CT and is a candidate for elective EMN bronchoscopic evaluation as determined by the treating pulmonologist,
The size of the target nodule, as measured at its greatest diameter, is between 1-3cm,
Staging at the time of enrollment indicates NO/N1 (does not involve lymph nodes or includes involvement in nodes within ipsilateral hilum),
The patient has an intermediate risk of malignancy (5-65% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (>65%) and will be referred for surgical evaluation or stereotactic body radiation therapy (SBRT). Note: If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study,

Key exclusion criteria (3 listed)

The patient is pregnant as confirmed by urine or serum pregnancy testing,
The patients has a body mass index (BMI) >40,
There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients with a nodule within SPiNPerc range (i.e. The patient would not go on for a CT guided TTNA), OR There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before SBRT.

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
Veran SystemAlso: Veran SPiN Thoracic Navigation System SPiNPerc KitElectromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration	Device	Veran System

Primary outcome

Diagnostic Yield
Time frame: Up to one year post index procedure
Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA

4 secondary outcomes

Serious Adverse Events
Time frame: 30 days post index procedure
Adverse Events
Time frame: 30 days post index procedure
Rate of procedure cancellation
Time frame: On procedure day
Procedural Factors
Time frame: Intra-procedure

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 19 May 2020.
Derived from this study: PubMed 37582154Thiboutot J, Pastis NJ, Akulian J, Silvestri GA, Chen A, Wahidi MM, Gilbert CR, Lin CT, Los J, Flenaugh E, Semaan R, Burks AC, Sathyanarayan P, Wu S, Feller-Kopman D, Cheng GZ, Alalawi R, Rahman NM, Maldonado F, Lee HJ, Yarmus L. A Multicenter, Single-Arm, Prospective Trial Assessing the Diagnostic Yield of Electromagnetic Bronchoscopic and Transthoracic Navigation for Peripheral Pulmonary Nodules. Am J Respir Crit Care Med. 2023 Oct 15;208(8):837-845. doi: 10.1164/rccm.202301-0099OC.
Derived from this study: PubMed 30675961Mallow C, Lee H, Oberg C, Thiboutot J, Akulian J, Burks AC, Luna B, Benzaquen S, Batra H, Cardenas-Garcia J, Toth J, Heidecker J, Belanger A, McClune J, Osman U, Lakshminarayanan V, Pastis N, Silvestri G, Chen A, Yarmus L. Safety and diagnostic performance of pulmonologists performing electromagnetic guided percutaneous lung biopsy (SPiNperc). Respirology. 2019 May;24(5):453-458. doi: 10.1111/resp.13471. Epub 2019 Jan 24.
Derived from this study: PubMed 29885373Thiboutot J, Lee HJ, Silvestri GA, Chen A, Wahidi MM, Gilbert CR, Pastis NJ, Los J, Barriere AM, Mallow C, Salwen B, Dinga MJ, Flenaugh EL, Akulian JA, Semaan R, Yarmus LB. Study Design and Rationale: A Multicenter, Prospective Trial of Electromagnetic Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules (ALL IN ONE Trial). Contemp Clin Trials. 2018 Aug;71:88-95. doi: 10.1016/j.cct.2018.06.007. Epub 2018 Jun 7.
Individual participant dataSharing planned: No

Related trials for Lung Cancer

RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
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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.

Lonny Yarmus, DO principal investigator

Johns Hopkins University

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Veran System in people with Lung Cancer, run by Veran Medical Technologies at 9 sites 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 7 inclusion and 3 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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.

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 (time frame: Up to one year post index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03338049, which also lists 3 linked publications.

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 19 May 2020.