Autonomix Medical has announced the initiation of a proof-of-concept clinical trial to evaluate transvascular RF ablation use in managing pain associated with pancreatic cancer.
The company concluded its site initiation for the human study.
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This new approach aims to ablate somatic nerves and alleviate pain in patients.
The study’s primary goal is to successfully target and ablate the nerves responsible for pain in pancreatic cancer patients using RF ablation via a transvascular method.
Autonomix said the trial will enrol 20 subjects at a single clinical site, with an additional five patients to be treated for procedural familiarity but excluded from the study’s objective analysis.
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Enrolment is anticipated to conclude by the end of this year.
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By GlobalDataAutonomix Medical’s catheter-based technology is designed to detect neural signals linked to pain or disease and accurately target those nerves for treatment.
The company positions this technology as an alternative to current pain management methods, which often involve systemic drugs or blind treatment of suspected areas, potentially leading to ineffective results and harmful side effects.
The technology’s initial focus is on addressing pain related to pancreatic cancer, where existing treatments like opioids or invasive ethanol injections offer limited relief and carry significant risks.
Autonomix Medical CEO Lori Bisson said: “We continue to make solid progress with our PoC human clinical study. This study is a very important step in validating our clinical and regulatory plans for our technology and as such, our team is dedicated to its successful execution.
“With the site initiation now complete, we are working to identify and train Principal Investigators for the study and remain on track to commence patient enrolment this quarter.”
The technology comprises a platform with the potential to address indications, including renal denervation, cardiology, and chronic pain management across a wide disease spectrum.
