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The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS) | Clinical Trials | Clareo Health

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

NCT02323854•Medtronic - MITG

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

•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.
+3 more criteria

Locations (4)

Mayo Clinic

Rochester, Minnesota, United States

Weill Cornell Medical College

New York, New York, United States

Rhode Island Hospital

Providence, Rhode Island, United States

University Hospital Frankfurt

Frankfurt, Germany

Key Dates

Start Date

January 1, 2015

Primary Completion Date

March 13, 2017

Completion Date

November 1, 2017

Last Updated

May 7, 2018

Enrollment

ACTUAL participants

Conditions

Lung Cancer

Interventions

Ablation

DEVICE

Surgical Resection

PROCEDURE

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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RECRUITINGPHASE2

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Non-Small-Cell Lung Cancer

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Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial