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

April 4, 2018 updated by: Medtronic - MITG
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • University Hospital Frankfurt
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Day
Ablation Zone Shape
Time Frame: Same day
Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape
Same day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Same Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 13, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

December 13, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVEMPR0437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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