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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ablation
Surgical Resection
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring primary, recurrent, metastatic lung tumor, ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic
  • Weill Cornell Medical College
  • Rhode Island Hospital
  • University Hospital Frankfurt

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ablation and Surgical Resection

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Ablation Zone Shape
Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape

Secondary Outcome Measures

Number of Participants With Complete or Incomplete Tumor Ablation
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.

Full Information

First Posted
December 13, 2014
Last Updated
April 4, 2018
Sponsor
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT02323854
Brief Title
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
Acronym
EMPRESS
Official Title
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 13, 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
primary, recurrent, metastatic lung tumor, ablation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ablation and Surgical Resection
Arm Type
Other
Arm Description
Ablation of lung tumor; followed by surgical resection of the ablation zone.
Intervention Type
Device
Intervention Name(s)
Ablation
Intervention Description
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Intervention Type
Procedure
Intervention Name(s)
Surgical Resection
Intervention Description
The planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure.
Primary Outcome Measure Information:
Title
Dose Response
Description
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.
Time Frame
1 Day
Title
Ablation Zone Shape
Description
Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape
Time Frame
Same day
Secondary Outcome Measure Information:
Title
Number of Participants With Complete or Incomplete Tumor Ablation
Description
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.
Time Frame
Same Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian E Dupuy, MD FACR
Organizational Affiliation
Lifespan-Rhode Island Hospital, Rhode Island, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University Hospital Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35070367
Citation
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.
Results Reference
derived

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

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