CREO - Microwave Ablation Feasibility Study

September 8, 2026 updated by: Banner Health

Investigator-Initiated Feasibility Study of a Novel Endoscopic Ultrasound Guided Microwave Ablation Device in Patients With Locally Advanced, Unresectable, or Metastatic Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center and Gateway Hospital
        • Contact:
    • California
      • Los Angeles, California, United States, 90048
        • Not yet recruiting
        • Cedars Sinai
        • Principal Investigator:
          • Barham Abu Dayyeh, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Not yet recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Ajay Singh, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic Rochester
        • Contact:
        • Principal Investigator:
          • Vinay Chandrasekhara, MD
        • Sub-Investigator:
          • Jad Abimansour, MD
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Not yet recruiting
        • University of Tennessee Medical
        • Principal Investigator:
          • Frank Gress, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Not yet recruiting
        • West Virginia University Medicine
        • Principal Investigator:
          • Shailendra Singh, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the success of energy delivery during treatment with the device
Time Frame: From first MWA procedure to the end of treatment at Week 5 or 9
Success of energy delivery as measured by presence of echogenic microbubbles visualized during EUS imaging AND generator-confirmed energy delivery.
From first MWA procedure to the end of treatment at Week 5 or 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the procedural safety
Time Frame: From first MWA treatment to final long term follow up at week 52
Procedural safety as measured by absence of unplanned terminations or major complications during or immediately following (within 2 weeks) of ablation procedure.
From first MWA treatment to final long term follow up at week 52
To evaluate clinical safety
Time Frame: From first MWA treatment to final long term follow up at week 52
Clinical safety as measured by occurrence and severity of AEs, SAEs, and ADEs related to the procedure.
From first MWA treatment to final long term follow up at week 52
To evaluate tolerability of treatment with the device
Time Frame: From first MWA treatment to final long term follow up at week 52
Tolerability as measured by patient-reported Numeric Pain Rating Scale pain score. Numeric Pain Rating Scale is scored 0-10, where "0" represents "no pain" and "10" represents "worst pain imaginable."
From first MWA treatment to final long term follow up at week 52
To evaluate the early antitumor effect of treatment with the device by change in size of target lesion.
Time Frame: From first MWA treatment to follow up visit at 6 months from first treatment
Early antitumor effect at 3 months and 6 months as measured by percent change in target lesion diameter on CT/MRI or maximal lesion diameter on EUS.
From first MWA treatment to follow up visit at 6 months from first treatment
To evaluate the early antitumor effect of treatment with the device by RECIST.
Time Frame: Time Frame: From first MWA treatment to follow up visit at 6 months from first treatment
Early antitumor effect at 3 months and 6 months as measured by Objective response rate (ORR), defined as complete response (CR) + partial response (PR) on CT/MRI, per Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame: From first MWA treatment to follow up visit at 6 months from first treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the technical success of the device
Time Frame: From first MWA treatment to final treatment at Week 5 or 9
Technical success of device as measured by reaching intended target tissue, successful delivery of MWA energy, and EUS imaging-confirmed achievement of ablation.
From first MWA treatment to final treatment at Week 5 or 9
To evaluate the correlation between changes in tumor marker CA 19-9 and antitumor effect of treatment with the device by change in size of target lesion (if data are available)
Time Frame: From first MWA treatment to End of Study (EOS) follow up at Week 26 or 52
Correlation between change in tumor markers, as measured by change in serum CA 19-9 tumor marker levels from baseline to EOS follow up at Week 26 or 52, and antitumor effect of treatment, as described in Secondary Outcome Measure #5.
From first MWA treatment to End of Study (EOS) follow up at Week 26 or 52
To evaluate the correlation between changes in tumor marker CA 19-9 and antitumor effect of treatment with the device by RECIST (if data are available)
Time Frame: Time Frame: From first MWA treatment to End of Study (EOS) follow up at Week 26 or 52
Correlation between change in tumor markers, as measured by change in serum CA 19-9 tumor marker levels from baseline to EOS follow up at Week 26 or 52, and antitumor effect of treatment, as described in Secondary Outcome Measure #6.
Time Frame: From first MWA treatment to End of Study (EOS) follow up at Week 26 or 52
To evaluate the long-term antitumor effect of treatment with the device (if data are available) by change in size of target lesion.
Time Frame: From first MWA treatment to long term follow up visit at Week 52
Long-term antitumor effect as measured by percent change in target lesion diameter on CT/MRI or maximal lesion diameter on EUS after 1-year follow-up.
From first MWA treatment to long term follow up visit at Week 52
To evaluate the long-term antitumor effect of treatment with the device (if data are available) by RECIST.
Time Frame: Time Frame: From first MWA treatment to long term follow up visit at Week 52
Long-term antitumor effect as measured by ORR, defined as CR + PR on CT/MRI per RECIST, after 1-year follow-up.
Time Frame: From first MWA treatment to long term follow up visit at Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banner Health

Collaborators

Creo Medical Limited
CreoMed, Inc.

Investigators

  • Principal Investigator: Neil Sharma, MD, Banner Health (Banner MD Anderson Cancer Center at Gateway Medical Center)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREO EUS MWA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data obtained from each institutional site will be pooled for aggregate analysis. Descriptive statistics will be used, with continuous variables presented as means, standard deviations, medians, and ranges; and categorical variables will be presented as frequencies and percentages.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe