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

Lung Cancer Clinical Trial

— EMPRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323854
• Other study ID #: COVEMPR0437
• Status: Completed
• Phase: N/A
• First received: December 13, 2014
• Last updated: April 4, 2018
• Start date: January 2015
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2017
• Est. primary completion date: March 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt
United States	Weill Cornell Medical College	New York	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ablation Zone Shape	Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape	Same day
Secondary	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.	Same Day