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

• ClinicalTrials.gov Identifier: NCT02323854
• Recruitment Status: Completed
• First Posted: December 24, 2014
• Results First Posted: April 5, 2018
• Last Update Posted: May 7, 2018
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Device: Ablation; Procedure: Surgical Resection	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
• Study Start Date: January 2015
• Actual Primary Completion Date: March 13, 2017
• Actual Study Completion Date: November 2017

Arms and Interventions

Arm	Intervention/treatment
Ablation and Surgical Resection; Ablation of lung tumor; followed by surgical resection of the ablation zone.	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.

Outcome Measures

Primary Outcome Measures :

1. Dose Response [ Time Frame: 1 Day ]
   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.
2. Ablation Zone Shape [ Time Frame: Same day ]
   Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape

Secondary Outcome Measures :

1. Number of Participants With Complete or Incomplete Tumor Ablation [ Time Frame: Same Day ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, New York

Weill Cornell Medical College

New York, New York, United States, 10065

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Germany

University Hospital Frankfurt

Frankfurt, Germany, 60590

Sponsors and Collaborators

Medtronic - MITG

Investigators

• Principal Investigator: Damian E Dupuy, MD FACR; Lifespan-Rhode Island Hospital, Rhode Island, USA

  Study Documents (Full-Text)

Documents provided by Medtronic - MITG:

Statistical Analysis Plan  [PDF] March 5, 2018

Study Protocol  [PDF] March 5, 2018

More Information

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT02323854
• Other Study ID Numbers: COVEMPR0437
• First Posted: December 24, 2014
• Results First Posted: April 5, 2018
• Last Update Posted: May 7, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Medtronic - MITG:

primary, recurrent, metastatic lung tumor, ablation

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases