The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
NCT02323854 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2018-05-07
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Medtronic - MITG
lead INDUSTRY
Principal Investigators
-
Damian E Dupuy, MD FACR · Lifespan-Rhode Island Hospital, Rhode Island, USA
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2017-03-13
- Completion
- 2017-11-30
- FDA Device
- Yes
Countries
- United States
- Germany
Study Locations
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