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NCT Number: NCT07817147

CREO - Microwave Ablation Feasibility Study

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Cancer (Locally Advanced or Metastatic) Liver Cancer Stage IIIa Liver Cancer Stage IIIb Liver Cancer Stage IIIc Liver Cancer Stage IV Liver Diseases Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Cancer Non-resectable Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banner MD Anderson Cancer Center and Gateway Hospital, Gilbert, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS-Guided MWA Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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."

  4. 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.

  5. 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).

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Neil Sharma, MD

CONTACT

[email protected]

(480) 356 - 6444

Sponsors and collaborators

Lead sponsor

Banner Health

Other

Collaborators

  • Creo Medical Limited
  • CreoMed, Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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