CREO - Microwave Ablation Feasibility Study

Banner Health

Status: Enrolling

Conditions: Pancreatic Cancer Non-resectable; Pancreatic Cancer Stage III; Liver Cancer (Locally Advanced or Metastatic); Liver Cancer Stage IIIb; Pancreatic Cancer Stage IV; Liver Cancer Stage IIIa; Liver Cancer Stage IIIc; Liver Cancer Stage IV; Pancreatic Cancer

Treatments: Device: EUS-Guided MWA Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07817147

CREO EUS MWA

Details and patient eligibility

About

The goal of this study is to assess the overall success of energy delivery during treatment using the ultrasound guided microwave ablation device in patients with locally advanced, unresectable, or metastatic cancer. Secondly, this study aims to explore the procedural/clinical safety of treatment with the device and the antitumor effect following treatment with the device.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ≥18 years of age
• Willing and able to provide written informed consent
• Histologically confirmed locally advanced, unresectable or metastatic cancer (Stage III or IV)
• At least 1 tumor that is indicated for MWA, and the location of target tumor must be accessible via EUS through the gastric wall (eg, pancreas, liver, etc).
• The tumor(s) must be ≥1 cm in diameter

Exclusion criteria

• Participant is a candidate for upfront resection of pancreatic cancer
• Participation in another clinical trial that involves local ablation or any other local therapy that could affect the target organ or lesions treated in this study
• Any condition that, in the opinion of the investigator, may increase the risk to the participant's safety or well-being

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Endoscopic Ultrasound (EUS) - Guided Microwave Ablation (MWA) Device Group

Other group

Description:

This is a open label feasibility study and only eligible participants will be enrolled into the single arm of the study to receive MWA with this specific device.

Treatment:

Device: EUS-Guided MWA Device