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

Completed · Not applicable

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT02323854

Run by

Medtronic - MITG

People needed

15

Starts

2015-01-01

Expected to finish

2017-11-01

Last updated by the study team

2018-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Weill Cornell Medical College — New York, New York, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• University Hospital Frankfurt — Frankfurt, Germany

Full record on ClinicalTrials.gov

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