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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.