N/A
N=15
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02323854 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Apr 2018
Primary outcome: Primary: Dose Response — -43.6; -15.1; -32.8; -63.5 percent difference
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ablation (Device); Surgical Resection (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Response |
-43.6; -15.1; -32.8; -63.5; -57.7 | — |
| PRIMARY Ablation Zone Shape |
0.6 | — |
| SECONDARY Number of Participants With Complete or Incomplete Tumor Ablation |
6; 4; 1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02323854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.