Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung

Broncus Medical

Status: Unknown

Conditions: Lung Diseases

Treatments: Device: Radiofrequency (RF) catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT04131777

Protocol 46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 2 patient groups

Roll-in

Description:

Initial patients enrolled until optimal RF algorithm is determined

Treatment:

Device: Radiofrequency (RF) catheter

Optimized

Description:

Patients treated using optimal RF algorithm

Treatment:

Device: Radiofrequency (RF) catheter