Clinical trial NCT04131777: Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
Official title: Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Diseases
Lead sponsor: Broncus Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Uptake Medical Technology, Inc.
First posted: 2019-10-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with non-small cell lung cancer (NSCLC) and/or pulmonary metastases that are recommended for curative lung resection (pneumonectomy, lobectomy). Enrolled patients will have a microscopically confirmed malignancy, ensuring patients are surgical candidates.

Brief summary: A post-market study to assess the performance and safety of a RF ablation catheter to bronchoscopically ablate lung lesions will be evaluated in patients with confirmed diagnosis of non-small cell lung cancer or metastatic lung lesions who are scheduled for surgical resection.

Detailed description: This study is a prospective, single-arm, multi-center, post-market study of bronchoscopic radio frequency (RF) ablation treatment malignant lung lesions prior to surgical resection. Up to 15 patients will be treated at the participating sites.

Patients identified for the study will have been scheduled for surgical resection as part of their treatment for lung lesions. The RF ablation procedure will be performed during a standard-of-care bronchoscopic procedure at minimum of 24 hours prior to resection. The patients exits the study following surgical resection. The resected tissue will undergo pathological evaluation for tissue viability.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years at screening
2. Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
3. Eligible for standard of practice lung resection (pneumonectomy, lobectomy)
4. Tumor/lesion \> 2cm along the major diameter with no visible necrosis
5. Signed informed consent form

Exclusion Criteria:

1. An implantable pacemaker, defibrillator, or other active implants
2. Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RF ablation

Primary outcomes:
measure: Performance - maximum diameter of zone of thermal necrosis surrounding treated lesion
timeFrame: The interval between ablation and tissue resection for pathological analysis is a minimum of 24 hours, but the exact interval depends on the investigator's standard of care
measure: Performance - ability of the user and device to deliver ablative treatment in accordance with the catheter's Instructions for Use
timeFrame: Assessed at the time of the RF ablation procedure
measure: Safety - Adverse events (AEs) and serious adverse events (SAEs)
timeFrame: AEs and SAEs related to the RF procedure/device will be reported for the interval beginning with the RF ablation procedure and ending with the surgical resection of the ablated lung tissueion
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
Study officials:
affiliation: Heidelberg University
name: Felix J Herth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: