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

Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.

Ablation

The planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure.

Surgical Resection

Damian E Dupuy, MD FACR

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.

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

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.

Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape

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.

Medtronic - MITG

All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.

Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.

Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit.

Ablation and Surgical Resection

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Germany

Region of Enrollment

Ablation procedures were completed for 15 subjects, of which 15 (100%) completed the study. Primary and secondary endpoint results were available for 11 subjects.

* Difficult to obtain the ablated tumor in resected sample
* Limitation to investigator to performing a single ablation
* Imaging was the only measure for dose response and was captured immediately post-procedure

Dr. Jaime Kean

% Change Ablation Zone Width (X)

% Change Ablation Zone Height (Y)

% Change Ablation Zone Depth (Z)

% Change (Actual Volume vs Predicted Volume)

% Change (Actual Calculated Vol. vs Predicted)

Primary endpoint results were available for 11 subjects. Four out of 15 (26.6%) imaging sets were either not obtained or unable to be evaluated.

Dose Response

Ablation Zone Shape

Complete Ablation

Incomplete Ablation

Delayed Necrosis

Secondary endpoint results were available for 11 subjects. For the secondary results, there were no tumors in four out of 15 samples (26.6%). Therefore, assessment of tumor cannot be made.

Number of Participants With Complete or Incomplete Tumor Ablation

All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.

Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.

Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data was collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit.

Spots Global Cancer Trial Database for primary, recurrent, metastatic lung tumor, ablation