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

NCT02323854 | Completed Results FDA Device

• 1 other identifier: COVEMPR0437
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 4

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.

Conditions

Lung Cancer

Keywords

primary, recurrent, metastatic lung tumor, ablation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of Participants With Complete or Incomplete Tumor Ablation

  Same Day

Study Arms (1)

Ablation and Surgical Resection

OTHER

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

Device: Ablation; Procedure: Surgical Resection

Interventions

Ablation DEVICE

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 and Surgical Resection

Surgical Resection PROCEDURE

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

Ablation and Surgical Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• \*Incidental intraprocedural finding that the subject no longer meets the study eligibility criteria.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University Hospital Frankfurt

Frankfurt, 60590, Germany

Location

Related Publications (1)

• Blackmon SH, Sterner RM, Eiken PW, Vogl TJ, Pua BB, Port JL, Dupuy DE, Callstrom MR. Technical and safety performance of CT-guided percutaneous microwave ablation for lung tumors: an ablate and resect study. J Thorac Dis. 2021 Dec;13(12):6827-6837. doi: 10.21037/jtd-21-594.

  PMID: 35070367 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

* 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

Results Point of Contact

• Title: Dr. Jaime Kean
• Organization: Medtronic

Jaime.m.Kean@medtronic.com

303-882-6759

Study Officials

• Damian E Dupuy, MD FACR

  Lifespan-Rhode Island Hospital, Rhode Island, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2014
• First Posted: December 24, 2014
• Study Start: January 1, 2015
• Primary Completion: March 13, 2017
• Study Completion: November 1, 2017
• Last Updated: May 7, 2018
• Results First Posted: April 5, 2018

Record last verified: 2018-04

Locations

DE (1); US (3)