The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-001772
    NCT ID: NCT02323854
    Sponsor Protocol Number: COVEMPR0437

About this study

Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Subject or authorized representative has provided informed consent.
  • Subject is ≥18 years of age.
  • At least one pulmonary metastasis ≤ 3.0 cm in maximum diameter resulting from distant primary cancers or at least one recurrence of primary lung cancer ≤ 3.0 cm in maximum diameter.
  • Subject has been confirmed by a thoracic surgeon to be a surgical candidate for resection of the tumor targeted for ablation.
  • Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
  • ≥1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure.

Exclusion Criteria:

  • Pre-procedure Exclusion Criteria
  • Contraindicated for surgery.
  • Prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery.
  • Tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or trachea.
  • Tumor with pleural contact.
  • Tumors located < 3 cm of staple lines or other metal objects.
  • Patients diagnosed with GOLD Stage IV Emphysema.
  • Uncontrollable coagulopathy
  • Patients unable to tolerate discontinued use of anti-coagulants prior to and during the ablation procedure.
  • Subject is pregnant (documented by a positive pregnancy test according to hospital standard practices) or is actively breast-feeding.
  • Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study.
  • The investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
  • Patients with implantable pacemakers and other electronic implants, in accordance with Instructions for Use (IFU).

Intraprocedural Exclusion Criteria

  • Incidental intraprocedural finding that the subject no longer meets the study eligibility criteria.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shanda Blackmon, M.D., M.P.H.

Closed for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

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CLS-20187340

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