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

B

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

Trial contacts and locations

1

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Central trial contact

Julie Arneson, BSc

Data sourced from clinicaltrials.gov

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