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A Clinical Study of Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer

Clinical Trial Details

This study is being done to look at the safety of delivering pulsed electric fields (PEF) to tumor(s) in patients with metastatic cancer within the lungs requiring biopsy, or tumor(s) from stage IV non-small cell lung cancer (NSCLC) requiring biopsy, who have not previously had treatment for the tumor(s), who are not surgical candidates, and who are considered eligible for first-line standard-of-care (SOC) cancer therapy. 
Participants will undergo the study PEF treatment procedure following completion of their standard-of-care diagnostic biopsy. This procedure will typically take place on the same day as the biopsy procedure. Additional biopsies will be taken for research purposes to evaluate the treatment effect on the tumor.

For the study PEF treatment procedure, the PEF energy is generated by the Aliya™ System, which consists of three key parts: the Aliya Generator, the Aliya Electrode, and the Aliya Percutaneous Needle. The Aliya System has been cleared by the U.S. Food and Drug Administration (FDA).

In this study, PEF energy may be delivered percutaneously (from a needle through the skin to the lung) or bronchoscopically (from within the lung airways). If the study doctor decides that it is appropriate to deliver the PEF energy percutaneously, they will use the Aliya Percutaneous Needle with the Aliya System which is FDA-cleared for soft tissue ablation.  If the study doctor decides that it is appropriate to deliver the PEF energy bronchoscopically, then the PEF energy will be delivered via the Aliya Endobronchial Needle. The Aliya System with the Aliya Percutaneous Needle and the Aliya Endobronchial Needle as used in this study is considered investigational. “Investigational” means that the study-specific use of the device has not been approved by the FDA outside this clinical study.

Participants will be asked to return for 3 follow-up assessments post-procedure. Blood samples will be collected as part of this study during the PEF procedure and during follow-ups post-procedure.

Total study participation is expected to last about 13 months, including standard of care follow-ups after study visits/assessments.

Key Eligibility: 
  1. Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV non-small cell lung cancer (NSCLC) requiring biopsy.
  2. Patient is deemed eligible to receive standard of care therapy for their malignancy.
  3. Patient is not a surgical candidate for curative intent, or the patient has refused surgery.
  4. Patient has not received any prior therapy for their cancer.
  5. Life expectancy of more than 6 months. 

Detailed eligibility will be discussed when reaching out to the study team.

Study contact by location

Upper East Side - Manhattan


Eli Gussen

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group