Clinical trial NCT02323854: The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
Official title: The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: primary, recurrent, metastatic lung tumor, ablation
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Dose Response
timeFrame: 1 Day
measure: Ablation Zone Shape
timeFrame: Same day
Secondary outcomes:
measure: Number of Participants With Complete or Incomplete Tumor Ablation
timeFrame: Same Day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
Study officials:
affiliation: Lifespan-Rhode Island Hospital, Rhode Island, USA
name: Damian E Dupuy, MD FACR
role: PRINCIPAL_INVESTIGATOR
References:
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.