NCT05723107

EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

Phase I Pilot Study of Endoscopic Ultrasound Guided RFA in Advanced Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm study in the treatment of pancreatic ductal adenocarcinoma (PDAC). The investigators propose to test the tolerability of chemotherapy plus endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using the RF Electrode in patients receiving palliative second or third line therapy for unresectable non-metastatic pancreatic cancer.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy	Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.
DEVICE	Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)	EUS-RFA will be delivered using the EUSRA RF Electrode, which is a sterile, single-use electrosurgical accessory for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator (VIVA Combo RF Generator). The device will be used during a routine EUS, which is a minimally invasive procedure used to assess gastrointestinal diseases. Each EUS-RFA procedure will last approximately 60 minutes.

Timeline

• Start date: 2023-03-31
• Primary completion: 2027-11-01
• Completion: 2028-03-01
• First posted: 2023-02-10
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study