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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Ablation
* Procedure: Surgical Resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ablation and Surgical Resection<br>Ablation of lung tumor; followed by surgical resection of the ablation zone. | Device: Ablation<br>* Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.<br>Procedure: Surgical Resection<br>* The planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Response | Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection. | 1 Day | 
| Ablation Zone Shape | Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape | Same day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete or Incomplete Tumor Ablation | The secondary endpoint was complete tumor ablation immediately post-procedure for each target tumor using histologic analysis. Complete ablation was defined as 100% nonviable tumor cells. | Same Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary, recurrent, metastatic lung tumor, ablation