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Completed

NCT Number: NCT02323854

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

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.

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Key information

Conditions

Lung Cancer Disease Attributes Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Frankfurt, Frankfurt, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ablation

Device

Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.

Surgical resection

Procedure

The planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure.

Primary outcomes

  1. 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.

  2. Ablation Zone Shape

    Time frame: Same day

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Acronym: EMPRESS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2014
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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