Percutaneous Localization: Open-label Registry of Thoracic Surgery

NCT04066699 | Completed FDA Device

• 1 other identifier: VMT-01-003
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 5

Brief Summary

The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools.

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)

Outcome Measures

Primary Outcomes (2)

• 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.

  Duration of procedure.

• Safety of the localization procedure.

  Safety data, including instances of adverse events and device deficiencies, will be collected.

  Duration of procedure.

Secondary Outcomes (5)

• Localization method and technique.

  Duration of procedure.

• Intraoperative percutaneous localization time and duration of total surgical procedure.

  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.

  Duration of procedure.

• Weight of excised tissue and margin.

  Duration of procedure.

• Type of surgical resection performed and the resection technique used.

  Duration of procedure.

Study Arms (1)

Localization

Electromagnetic navigation (EMN) guided percutaneous localization of suspicious lung lesion(s).

Procedure: Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.

Interventions

Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools. PROCEDURE

Transthoracic localization of suspicious lung lesion(s) in preparation for subsequent resection.

Also known as: SPiN Thoracic Navigation System™, Veran System

Localization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Veran Medical Technologies: lead

Study Sites (5)

Kaiser Permanente

Lone Tree, Colorado, 80124, United States

Location

Northern Light Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 27367891 BACKGROUND

• 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.

  PMID: 30675961 BACKGROUND

• 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.

  PMID: 29885373 BACKGROUND

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Faiz Bhora, MD

  Hackensack Meridian Health Network & School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: October 10, 2019
• Primary Completion: January 5, 2023
• Study Completion: February 9, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)