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.
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).
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
Single group
EUS-Guided MWA Device
DeviceThe 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.
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.
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.
To evaluate clinical safety
Clinical safety as measured by occurrence and severity of AEs, SAEs, and ADEs related to the procedure.
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."
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
