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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
Banner MD Anderson Cancer Center and Gateway Hospital
Gilbert, Arizona, United States
RECRUITINGCedars Sinai
Los Angeles, California, United States
NOT_YET_RECRUITINGRush University Medical Center
Chicago, Illinois, United States
NOT_YET_RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
NOT_YET_RECRUITINGUniversity of Tennessee Medical
Knoxville, Tennessee, United States
NOT_YET_RECRUITINGMemorial Hermann-Texas Medical Center
Houston, Texas, United States
NOT_YET_RECRUITINGWest Virginia University Medicine
Morgantown, West Virginia, United States
NOT_YET_RECRUITINGTo 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
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
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
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
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
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
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