CompletedNot applicableNCT02323854

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

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.

Checked against the public recordLast updated May 7, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations4
SponsorMedtronic - MITG
01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Medtronic - MITG
Interventions being studied
Device: Ablation; Procedure: Surgical Resection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo ClinicRochester, Minnesota
  • Weill Cornell Medical CollegeNew York, New York
  • Rhode Island HospitalProvidence, Rhode Island
  • University Hospital FrankfurtFrankfurt

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 7, 2018. Always confirm current availability with the study team.

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