CREO - Microwave Ablation Feasibility Study

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
This is a prospective feasibility study; therefore, no randomization is being performed.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Endoscopic Ultrasound (EUS) - Guided Microwave Ablation (MWA) Device Group 		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.
  • Device: EUS-Guided MWA Device
    The rationale of this study is to generate preliminary data on the functionality and safety of Creo's MicroBlate™ Fine device when used under EUS guidance. The results generated from this study will inform any decisions regarding subsequent pivotal trials and may support the integration of this approach into clinical practice for anatomically challenging tumors.

Recruiting Locations

Banner MD Anderson Cancer Center and Gateway Hospital
Gilbert, Arizona 85234
Contact:
Neil Sharma, MD
480-256-6444
neil.sharma@bannerhealth.com

More Details

Status
Recruiting
Sponsor
Banner Health

Study Contact

Neil Sharma, MD
(480) 356 - 6444
neil.sharma@bannerhealth.com