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



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:January 2015
End Date:November 2017

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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.

Primary Endpoint: Dose response as indicated by CT imaging, measurement of maximum diameter
and volume.

Secondary Endpoint: Assessment of complete tumor ablation immediately post-procedure.

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.
We found this trial at
4
sites
New York, New York 10021
Principal Investigator: Jeffery Port, MD
Phone: 212-746-3328
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Phone: 401-444-2277
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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7 Theodor-Stern-Kai
Frankfurt, 60590
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Frankfurt,
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Rochester, Minnesota 55905
Principal Investigator: Matthew Callstrom, MD
Phone: 507-293-0807
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Rochester, MN
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