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

Medtronic

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: Surgical Resection; Device: Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02323854

COVEMPR0437

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Ablation and Surgical Resection

Other group

Description:

Ablation of lung tumor; followed by surgical resection of the ablation zone.

Treatment:

Device: Ablation

Procedure: Surgical Resection