Clinical trial · Interventional
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
NCT02323854CI-TRIAL-00032808EMPRESScompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablation | Device | — | UNRESOLVED |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Ablation and Surgical Resection
- description
- Ablation of lung tumor; followed by surgical resection of the ablation zone.
- interventionNames
- Device: Ablation
- Procedure: Surgical Resection
Primary outcomes (2)
- measure
- Dose Response
- timeFrame
- 1 Day
- description
- 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.
- measure
- Ablation Zone Shape
- timeFrame
- Same day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBlackmon 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. PMID 35070367