ClinicalTrials.gg
RecruitingNCT07817147Updated Nov 6, 2026

CREO - Microwave Ablation Feasibility Study

An interventional study of EUS-Guided MWA Device in Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic) and Pancreatic Cancer Non-resectable, sponsored by Banner Health. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Banner Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Updated Nov 6, 20261 site removedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,852 studies in Pancreatic Neoplasms with a site in United States — 305 open to participants now, 477 under way, 25 of them phase 3. Pancreatic Neoplasms · United States.

Planned enrollment
436th of 1,575
75 · median 37
Started
2026
with 83 others
No phase
246 of 1,852
50 open now
Primary completion
2028-02
later than 312 of 474 live
Registered
1,787th of 1,852
by date

Among the 1,852 studies in Pancreatic Neoplasms with a site in United States, this one is the 436th largest by planned enrollment of the 1,575 interventional ones, is one of 84 that started in 2026, is one of 246 with no phase, reaches primary completion later than 312 of the 474 other live ones, and was the 1,787th registered.

By phase

1,852 studies; the count open now beside each. This study's row is marked.

Phase 1556 · 76 open
Phase 2488 · 45 open
No phasethis study246 · 50 open
Observational231 · 71 open
Phase 1/2223 · 44 open
Phase 380 · 14 open
Phase 412 · 0 open
Phase 2/311 · 3 open
Other kind5 · 2 open

By the year they started

First in 1991; this study’s year is marked. 84 started in 2026.

Size and results

Median enrollment 37 across the 1,575 interventional studies, 137 across the 230 observational. Of the 1,219 that completed or were terminated, 478 (39%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 1,852 studies in Pancreatic Neoplasms with a site in United States, or all of them as a file.
02

Study 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. Secondly, this study aims to explore the procedural/clinical safety of treatment with the device and the antitumor effect following treatment with the device.

03

Conditions studied

  • 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

Keywords

  • Locally Advanced
  • Unresectable
  • Metastatic
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female ≥18 years of age
  • Willing and able to provide written
  • confirmed locally advanced, unresectable or 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

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceEUS-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.

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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."

    Time frame: 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.

    Time frame: 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).

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

Other outcomes

  1. To evaluate the technical success of the device

    Technical success of device as measured by reaching intended target tissue, successful delivery of MWA energy, and EUS imaging-confirmed achievement of ablation.

    Time frame: From first MWA treatment to final treatment at Week 5 or 9

  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)

    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.

    Time frame: From first MWA treatment to End of Study (EOS) follow up at Week 26 or 52

  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)

    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: Time Frame: From first MWA treatment to End of Study (EOS) follow up at Week 26 or 52

  4. To evaluate the long-term antitumor effect of treatment with the device (if data are available) by change in size of target lesion.

    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.

    Time frame: From first MWA treatment to long term follow up visit at Week 52

  5. To evaluate the long-term antitumor effect of treatment with the device (if data are available) by RECIST.

    Long-term antitumor effect as measured by ORR, defined as CR + PR on CT/MRI per RECIST, after 1-year follow-up.

    Time frame: Time Frame: From first MWA treatment to long term follow up visit at Week 52

07

Study locations

1 of 6 sites recruiting
  • Banner MD Anderson Cancer Center and Gateway Hospital
    Gilbert, Arizona 85234, United States
    Recruiting
  • Cedars Sinai
    Los Angeles, California 90048, United States
    Not yet recruiting
    • Sara Karameh · ContactSara.karameh@cshs.org · 310-423-6082
    • Barham Abu Dayyeh, MD · Principal investigator
  • Rush University Medical Center
    Chicago, Illinois 60607, United States
    Not yet recruiting
  • University of Tennessee Medical
    Knoxville, Tennessee 37920, United States
    Not yet recruiting
    • Brandy Herbert · Contactbherbert@utmck.edu · 865-305-5120
    • Frank Gress, MD · Principal investigator
  • Memorial Hermann-Texas Medical Center
    Houston, Texas 77030, United States
    Not yet recruiting
  • West Virginia University Medicine
    Morgantown, West Virginia 26506, United States
    Not yet recruiting
    • Chad Glaze · Contactcglaze@hsc.wvu.edu · 304-293-9195
    • Shailendra Singh, MD · Principal investigator
08

References and documents

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.

Individual participant data

Plan to share: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Feb 2028, 24 months after the start.

Of 403 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's planned 24 months is below that.

Counting every sponsor, half of 430 studies reached it within 44 months; a quarter within 26 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2026
First posted
Sep 14, 2026
StartActual
Feb 19, 2026
Primary completionEst.
Feb 2028
CompletionEst.
Aug 2028
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site removed
Show 1 removed
  • Mayo Clinic Rochester · Rochester, United States
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    1 site removed
    Show 1 removed
    • Mayo Clinic Rochester · Rochester, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07817147
Lead sponsor
Banner Health
Collaborators
Creo Medical Limited, CreoMed, Inc.
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Feb 19, 2026
Primary completion
Feb 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Neil Sharma, MD
Contact
neil.sharma@bannerhealth.com
(480) 356 - 6444
Neil Sharma, MD
principal investigator · Banner Health (Banner MD Anderson Cancer Center at Gateway Medical Center)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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