Lung Lesion(s) Requiring EvaluationPLOTSNCT04066699
Percutaneous Localization: Open-label Registry of Thoracic Surgery
An observational study of Lung Lesion(s) Requiring Evaluation and Pulmonary Metastasis, run by Veran Medical Technologies at 5 sites in United States.
Trial summary
The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Lesion(s) Requiring Evaluation, Pulmonary Metastasis, Pulmonary Nodule, Solitary
- What is being tested?
- Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Oct 2019to 9 Feb 2023
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- 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
Study population: The target subject population includes adult subjects (18 years - 85 years), with small, suspicious lung lesions. Patients with small, indeterminate PPNs that, in the judgment of the thoracic surgeon, based on surgical risk and risk of malignancy, warrant lung resection via a percutaneous localization approach. Data will be collected from study subjects having a PPN between 0.4 cm and 3.2 cm in greatest dimension, that are accessible to percutaneous localization, who consent to and undergo intraoperative dye/wire localization procedure followed by surgical lung resection.
Who may be able to join
- Subject's physician and/or thoracic surgeon have deemed/has deemed that the surgical removal of the PPN is appropriate.
- A clinical decision has been made to use the SPiN Thoracic Navigation System™.
- Subject is at least 18 years of age at time of study entry.
- Subject is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures. IRB- approved translation may be used if indicated. Reasonable accommodation of visually impaired subjects will be allowed.
- Subject is able to tolerate general anesthesia.
- Subject has a target nodule between 0.4 cm and 3.2 cm in greatest dimension;
- The target nodule is in a location that is accessible for percutaneous localization in the judgement of the surgeon.
Who cannot join
- Subjects with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render peripheral nodule resection more hazardous than beneficial.
- Subject is pregnant.
- Pulmonary nodule is greater than 3.2 cm.
- Subjects with significant coagulopathy having INR > 2.0 or PTT > 2x normal.
- Subject is unable to tolerate general anesthesia.
- Obese subject, impacting percutaneous access (BMI > 50).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Houston Methodist Hospital
Houston, Texas, 77030
Kaiser Permanente
Lone Tree, Colorado, 80124
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
About this study
Official title: Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.
The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools.
Read the detailed description
The Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes (PLOTS) registry is aimed at developing a high quality set of data regarding intraoperative percutaneous localization of peripheral pulmonary nodules (PPNs), and then identifying and promulgating efficient, evidence-based best practices for this technique. The resection procedure itself is standard of care and follows the investigator's standard protocol.
Successful localization of PPNs is a challenge involving multiple factors, beginning with the subjects' health, lung function and also factors specific to the nodule including location within the lung, size, distance from the lung surface, whether solid or ground glass and proximity to a fissure. Hard to see or palpate nodules are currently localized with dye and/or hook wires or fiducials, either endoscopically or percutaneously. Successful, large, prospective studies have not been reported using modern electro-magnetic navigation (EMN)-guided percutaneous intraoperative localization, and different techniques (dye vs. fiducial vs. hook wire etc.) have not been broadly evaluated. It is for these reasons that the different localization techniques used with EMN-guided percutaneous localization will be collected for patients having a suspicious nodule and who undergo percutaneous intra-operative localization and immediate resection.
This registry aims to record the localization techniques used by thoracic surgeons and IP/surgical teams to identify PPNs using the SPiN Thoracic Navigation System™ in the hands of trained physicians. The objectives of this study will be to accomplish the primary and secondary objectives listed below, and to observe localization in a real world context of pulmonary resection.
- Conditions
- Lung Lesion(s) Requiring Evaluation, Pulmonary Metastasis, Pulmonary Nodule, Solitary, Peripheral Lung Lesions
- Being tested
- Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.
- Keywords
- Surgical Lung Resection, Percutaneous Localization, Electromagnetic Navigation, Transthoracic Localization, Peripheral Pulmonary Nodule(s)
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.Procedure or surgery
Also called SPiN Thoracic Navigation System™, Veran System
Transthoracic localization of suspicious lung lesion(s) in preparation for subsequent resection.
| Study group | Role | What they receive |
|---|---|---|
| Localization | Electromagnetic navigation (EMN) guided percutaneous localization of suspicious lung lesion(s). Receives: Procedure: Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful percutaneous localization and removal of PPN.
Successful percutaneous localization of PPN defined as the percentage of subjects in whom the nodule is successfully localized and removed in the first resected specimen.
Measured: Duration of procedure.
Safety of the localization procedure.
Safety data, including instances of adverse events and device deficiencies, will be collected.
Measured: Duration of procedure.
Secondary outcomes (5)
Localization method and technique.
Details regarding the localization technique will be collected, including the materials used. If dye (methylene blue, ICG etc.) is used the volume will be collected. Other materials include microcoils, hook wires, etc..
Measured: Duration of procedure.
Intraoperative percutaneous localization time and duration of total surgical procedure.
The time of the localization procedure will be recorded. The length of the entire surgical procedure will also be recorded.
Measured: Duration of procedure.
Nodule characteristics, including location in the lobe, distance from pleura, distance from surface of skin to target, morphological appearance, solid vs. ground glass etc.
Details regarding nodule characteristics - solid, semisolid, groundglass; location in relation to anatomical markers and position; size; presence of spiculation - will be collected.
Measured: Duration of procedure.
Weight of excised tissue and margin.
The weight (in grams) of excised tissue will be recorded, as well as the measurement of the included margin.
Measured: Duration of procedure.
Type of surgical resection performed and the resection technique used.
The surgical resection may include segmentectomy or wedge using the VATS, RATS, or thoracotomy techniques.
Measured: Duration of procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start10 Oct 2019
- Primary completion5 Jan 2023
- Study completion9 Feb 2023
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 Lesion(s) Requiring EvaluationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Veran Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Faiz Bhora, MD, Principal investigator, Hackensack Meridian Health Network & School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066699
- Sponsor's protocol ID
- VMT-01-003
- Acronym
- PLOTS
- Status last verified
- May 2024
- First submitted
- 21 Aug 2019
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Semaan RW, Lerner AD, Lee HJ, Feller-Kopman D, Yarmus LB. Electromagnetic Guidance for the Diagnosis of Pulmonary Nodules: Don't Put the Nail in the Coffin. Am J Respir Crit Care Med. 2016 Jul 1;194(1):121. doi: 10.1164/rccm.201602-0243LE. No abstract available.
PubMed 27367891Mallow 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 30675961Thiboutot 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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.
- ClinicalTrials.gov ID
- NCT04066699
- Acronym / sponsor ID
- PLOTS / VMT-01-003
- Conditions
- Lung Lesion(s) Requiring Evaluation, Pulmonary Metastasis, Pulmonary Nodule, Solitary, Peripheral Lung Lesions
- Keywords
- Surgical Lung Resection, Percutaneous Localization, Electromagnetic Navigation, Transthoracic Localization, Peripheral Pulmonary Nodule(s)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Veran Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 26 Aug 2019 (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.
The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools.
Detailed description
The Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes (PLOTS) registry is aimed at developing a high quality set of data regarding intraoperative percutaneous localization of peripheral pulmonary nodules (PPNs), and then identifying and promulgating efficient, evidence-based best practices for this technique. The resection procedure itself is standard of care and follows the investigator's standard protocol.
Successful localization of PPNs is a challenge involving multiple factors, beginning with the subjects' health, lung function and also factors specific to the nodule including location within the lung, size, distance from the lung surface, whether solid or ground glass and proximity to a fissure. Hard to see or palpate nodules are currently localized with dye and/or hook wires or fiducials, either endoscopically or percutaneously. Successful, large, prospective studies have not been reported using modern electro-magnetic navigation (EMN)-guided percutaneous intraoperative localization, and different techniques (dye vs. fiducial vs. hook wire etc.) have not been broadly evaluated. It is for these reasons that the different localization techniques used with EMN-guided percutaneous localization will be collected for patients having a suspicious nodule and who undergo percutaneous intra-operative localization and immediate resection.
This registry aims to record the localization techniques used by thoracic surgeons and IP/surgical teams to identify PPNs using the SPiN Thoracic Navigation System™ in the hands of trained physicians. The objectives of this study will be to accomplish the primary and secondary objectives listed below, and to observe localization in a real world context of pulmonary resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Localization | – | Procedure: Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.Electromagnetic navigation (EMN) guided percutaneous localization of suspicious lung lesion(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target subject population includes adult subjects (18 years - 85 years), with small, suspicious lung lesions. Patients with small, indeterminate PPNs that, in the judgment of the thoracic surgeon, based on surgical risk and risk of malignancy, warrant lung resection via a percutaneous localization approach. Data will be collected from study subjects having a PPN between 0.4 cm and 3.2 cm in greatest dimension, that are accessible to percutaneous localization, who consent to and undergo intraoperative dye/wire localization procedure followed by surgical lung resection.
Key inclusion criteria (7 listed)
- Subject's physician and/or thoracic surgeon have deemed/has deemed that the surgical removal of the PPN is appropriate.
- A clinical decision has been made to use the SPiN Thoracic Navigation System™.
- Subject is at least 18 years of age at time of study entry.
- Subject is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures. IRB- approved translation may be used if indicated. Reasonable accommodation of visually impaired subjects will be allowed.
- Subject is able to tolerate general anesthesia.
Key exclusion criteria (6 listed)
- Subjects with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render peripheral nodule resection more hazardous than beneficial.
- Subject is pregnant.
- Pulmonary nodule is greater than 3.2 cm.
- Subjects with significant coagulopathy having INR > 2.0 or PTT > 2x normal.
- Subject is unable to tolerate general anesthesia.
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 |
|---|---|---|
| Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.Also: SPiN Thoracic Navigation System™, Veran SystemTransthoracic localization of suspicious lung lesion(s) in preparation for subsequent resection. | Procedure or surgery | Localization |
Primary outcome
Rate of successful percutaneous localization and removal of PPN.
Time frame: Duration of procedure.
Successful percutaneous localization of PPN defined as the percentage of subjects in whom the nodule is successfully localized and removed in the first resected specimen.
Safety of the localization procedure.
Time frame: Duration of procedure.
Safety data, including instances of adverse events and device deficiencies, will be collected.
5 secondary outcomes
Localization method and technique.
Time frame: Duration of procedure.
Intraoperative percutaneous localization time and duration of total surgical procedure.
Time frame: Duration of procedure.
Nodule characteristics, including location in the lobe, distance from pleura, distance from surface of skin to target, morphological appearance, solid vs. ground glass etc.
Time frame: Duration of procedure.
Weight of excised tissue and margin.
Time frame: Duration of procedure.
Type of surgical resection performed and the resection technique used.
Time frame: Duration of 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 17 May 2024.
- Background: PubMed 27367891Semaan RW, Lerner AD, Lee HJ, Feller-Kopman D, Yarmus LB. Electromagnetic Guidance for the Diagnosis of Pulmonary Nodules: Don't Put the Nail in the Coffin. Am J Respir Crit Care Med. 2016 Jul 1;194(1):121. doi: 10.1164/rccm.201602-0243LE. No abstract available.
- Background: 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.
- Background: 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
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.
Faiz Bhora, MD principal investigator
Hackensack Meridian Health Network & School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Lesion(s) Requiring Evaluation and Pulmonary Metastasis, run by Veran Medical Technologies at 5 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 6 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 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Rate of successful percutaneous localization and removal of PPN. (time frame: Duration of procedure.). The study lists 2 primary outcomes in all. 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 NCT04066699, 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 17 May 2024.