The REMOVE Study – Endobronchial Thermal Liquid Ablation – Lung Cancer (ETLA-LC) for the Treatment of Pulmonary Cancer Lesions – A First in Human Treat and Resect Study (CSP-21123)

ACTRN 12624001045505

Brief Summary

The aim of this study is to evaluate the safety and feasibility of Endobronchial thermal liquid ablation (ETLA-LC) for the Treatment of Pulmonary Cancer Lesions.

Intervention/Treatment

  • Device: Endobronchial Thermal Liquid Ablation – Lung Cancer (ETLA-LC).

Inclusion Criteria

General Inclusion Criteria:

  • Age greater than or equal to 18 years old.
  • Non-small cell lung cancer tumor(s) suitable for lobectomy.
  • Suitable candidate for lobectomy as per standard of care.
  • Pathologically confirmed malignancy obtained via bronchoscopic biopsy with adequate yield to perform definitive diagnosis.
  • Cognitively able to provide written informed consent.

Radiographic Inclusion Criteria

  • Longest axis of tumor less than 3cm per HRCT analysis by QCT Core lab.
  • Tumor is identified in the periphery of lung (outer 2/3rd) by radiologic reviewer in addition to site radiologist.
  • Tumor resides in eligible segment(s) per HRCT analysis by QCT Core lab, with target treatment location not adjacent to lobar fissure planned for resection, and assessed by surgeon.
  • Tumor resides within two or fewer eligible segments per HRCT analysis by QCT Core lab with treatment at the segmental or subsegmental level.

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