Clinical trial · Interventional
CREO - Microwave Ablation Feasibility Study
Investigator-Initiated Feasibility Study of a Novel Endoscopic Ultrasound Guided Microwave Ablation Device in Patients With Locally Advanced, Unresectable, or Metastatic Cancer
NCT07817147CI-TRIAL-00126284recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer (Locally Advanced or Metastatic) | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
| Liver Cancer Stage IIIa | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Liver Cancer Stage IIIb | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Liver Cancer Stage IIIc | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Liver Cancer Stage IV | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer Non-resectable | — | UNRESOLVED | — |
| Pancreatic Cancer Stage III | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer Stage IV | Malignant Pancreatic Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-Guided MWA Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Endoscopic Ultrasound (EUS) - Guided Microwave Ablation (MWA) Device Group
- description
- 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.
- interventionNames
- Device: EUS-Guided MWA Device
Primary outcomes (1)
- measure
- To assess the success of energy delivery during treatment with the device
- timeFrame
- From first MWA procedure to the end of treatment at Week 5 or 9
- description
- Success of energy delivery as measured by presence of echogenic microbubbles visualized during EUS imaging AND generator-confirmed energy delivery.
Secondary outcomes (5)
- measure
- To evaluate the procedural safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDUS Food and Drug Administration. 510(k) Premarket Notification: Creo Electrosurgical System with NP1 Instrument. K221672. Published 2023. Accessed December 2025: K221672.pdf.
- BACKGROUNDSuwa 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. PMID 33675382
- BACKGROUNDMaiettini 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. PMID 31537162
- BACKGROUNDHiremath S. Ablation technologies and medical devices: revolutionizing medical treatments. Int J Innovative Res Med Sci. 2019;4(4):1-8.
- BACKGROUNDFacciorusso 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. PMID 33339274
- BACKGROUNDCreo 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.
- BACKGROUNDCampbell 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. PMID 39061199
- BACKGROUNDAmerican Cancer Society. Liver cancer ablation: RFA, MWA, cryotherapy, PEI, histotripsy. Cancer.org. Updated 2024.