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Pancreatic CancerNCT07817147

CREO - Microwave Ablation Feasibility Study

A study testing EUS-Guided MWA Device in people with Pancreatic Cancer and Liver Cancer (Locally Advanced or Metastatic), run by Banner Health at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EUS-Guided MWA Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
7 sitesUnited States
Study dates
19 Feb 2026to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Neil Sharma, MD contact

(480) 356 - 6444

neil.sharma@bannerhealth.com

7 sites in 1 country

United States7 sites, 7 recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60607

    Amanda Lin, 312-563-3907, Amanda_F_Lin@rush.edu

    Ajay Singh, MD

    Not yet recruiting

  • Banner MD Anderson Cancer Center and Gateway Hospital

    Gilbert, Arizona, 85234

    Neil Sharma, MD, 480-256-6444, neil.sharma@bannerhealth.com

    Recruiting

  • Memorial Hermann-Texas Medical Center

    Houston, Texas, 77030

    Cecelia Lara, 713-500-6529, Cecilia.Lara@uth.tmc.edu

    Nicole Fatheree, Nicole.Fatheree@uth.tmc.edu

    Not yet recruiting

  • University of Tennessee Medical

    Knoxville, Tennessee, 37920

    Brandy Herbert, 865-305-5120, bherbert@utmck.edu

    Frank Gress, MD

    Not yet recruiting

  • Cedars Sinai

    Los Angeles, California, 90048

    Sara Karameh, 310-423-6082, Sara.karameh@cshs.org

    Barham Abu Dayyeh, MD

    Not yet recruiting

  • West Virginia University Medicine

    Morgantown, West Virginia, 26506

    Chad Glaze, 304-293-9195, cglaze@hsc.wvu.edu

    Shailendra Singh, MD

    Not yet recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Elizabeth Lemke, 507-266-3317, Lemke.Elizabeth@mayo.edu

    Vinay Chandrasekhara, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
EUS-Guided MWA Device
Keywords
Locally Advanced, Unresectable, Metastatic
Medical subject headings
Pancreatic Neoplasms, Liver Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUS-Guided MWA DeviceDevice

    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.

Study groups in NCT07817147
Study groupRoleWhat they receive
Endoscopic Ultrasound (EUS) - Guided Microwave Ablation (MWA) Device GroupOtherThis 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.
Receives: Device: EUS-Guided MWA Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the success of energy delivery during treatment with the device

    Success of energy delivery as measured by presence of echogenic microbubbles visualized during EUS imaging AND generator-confirmed energy delivery.

    Measured: From first MWA procedure to the end of treatment at Week 5 or 9

Secondary outcomes (5)

  1. To evaluate the procedural safety

    Procedural safety as measured by absence of unplanned terminations or major complications during or immediately following (within 2 weeks) of ablation procedure.

    Measured: From first MWA treatment to final long term follow up at week 52

  2. To evaluate clinical safety

    Clinical safety as measured by occurrence and severity of AEs, SAEs, and ADEs related to the procedure.

    Measured: From first MWA treatment to final long term follow up at week 52

  3. To evaluate tolerability of treatment with the device

    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."

    Measured: From first MWA treatment to final long term follow up at week 52

  4. To evaluate the early antitumor effect of treatment with the device by change in size of target lesion.

    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.

    Measured: From first MWA treatment to follow up visit at 6 months from first treatment

  5. To evaluate the early antitumor effect of treatment with the device by RECIST.

    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).

    Measured: Time Frame: From first MWA treatment to follow up visit at 6 months from first treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start19 Feb 2026
  3. Primary completionFeb 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective feasibility study; therefore, no randomization is being performed.
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07817147
Sponsor's protocol ID
CREO EUS MWA
Status last verified
Sep 2026
First submitted
18 Feb 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: 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.

Publications

  • US Food and Drug Administration. 510(k) Premarket Notification: Creo Electrosurgical System with NP1 Instrument. K221672. Published 2023. Accessed December 2025: K221672.pdf.

  • Suwa K, Seki T, Aoi K, Yamashina M, Murata M, Yamashiki N, Nishio A, Shimatani M, Naganuma M. Efficacy of microwave ablation versus radiofrequency ablation for hepatocellular carcinoma: a propensity score analysis. Abdom Radiol (NY). 2021 Aug;46(8):3790-3797. doi: 10.1007/s00261-021-03008-9. Epub 2021 Mar 6.

    PubMed 33675382

  • Maiettini D, Mauri G, Varano G, Bonomo G, Della Vigna P, Rebonato A, Orsi F. Pancreatic ablation: minimally invasive treatment options. Int J Hyperthermia. 2019 Oct;36(2):53-58. doi: 10.1080/02656736.2019.1647354.

    PubMed 31537162

  • Hiremath S. Ablation technologies and medical devices: revolutionizing medical treatments. Int J Innovative Res Med Sci. 2019;4(4):1-8.

  • Facciorusso A, Abd El Aziz MA, Tartaglia N, Ramai D, Mohan BP, Cotsoglou C, Pusceddu S, Giacomelli L, Ambrosi A, Sacco R. Microwave Ablation Versus Radiofrequency Ablation for Treatment of Hepatocellular Carcinoma: A Meta-Analysis of Randomized Controlled Trials. Cancers (Basel). 2020 Dec 16;12(12):3796. doi: 10.3390/cancers12123796.

    PubMed 33339274

  • Creo Medical. MicroBlate Fine for the ablation of soft tissue. Creo Medical website. Accessed October 23, 2025. https://www.creomedical.com/en/kamaptive-technology/microblate-fine.

  • Campbell WA 4th, Makary MS. Advances in Image-Guided Ablation Therapies for Solid Tumors. Cancers (Basel). 2024 Jul 17;16(14):2560. doi: 10.3390/cancers16142560.

    PubMed 39061199

  • American Cancer Society. Liver cancer ablation: RFA, MWA, cryotherapy, PEI, histotripsy. Cancer.org. Updated 2024.

Questions about this trial

What is this clinical trial studying?

A study testing EUS-Guided MWA Device in people with Pancreatic Cancer and Liver Cancer (Locally Advanced or Metastatic), run by Banner Health at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Neil Sharma, MD ((480) 356 - 6444, neil.sharma@bannerhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07817147, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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