NCT02323854

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Ablation	Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
PROCEDURE	Surgical Resection	The planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-03-13
• Completion: 2017-11-01
• First posted: 2014-12-24
• Last updated: 2018-05-07
• Results posted: 2018-04-05

Locations

4 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study