Associate Professor of Medicine Stanford University School of Medicine Stanford, CA
Bernardo Goecke, MD1, Karina Carcamo, MD1, Jose I. Vargas, MD2, Jan Cubilla, MD3, Walter Park, MD41Hospital Base Osorno, Osorno, Los Lagos, Chile; 2School of Medicine Pontifica Universidad Catolica, Santiago, Region Metropolitana, Chile; 3Hospital Santo Tomás, Provincia de Panamá, Panama, Panama; 4Stanford University School of Medicine, Stanford, CA Introduction: Patients with AP who presented within 72 hours of symptom onset were recruited to participate in this study (NCT06849336). Eligible participants received localized cooling which was achieved within the closed-circuit catheter circulating 4°C water from an FDA-cleared heat exchanger. Cooling therapy was provided for up to 72 hours. Primary endpoints were technical success (catheter placement, cooling) and incidence of adverse events (AE). Secondary endpoints included changes in PASS score (Pancreatic Activity Scoring System). Methods: Patients with AP who presented within 72 hours of symptom onset were recruited to participate in this study (NCT06849336). Eligible participants received localized cooling which was achieved within the closed-circuit catheter circulating 4°C water from an FDA-cleared heat exchanger. Cooling therapy was provided for up to 72 hours. Primary endpoints were technical success (catheter placement, cooling) and incidence of adverse events (AE). Secondary endpoints included changes in PASS score (Pancreatic Activity Scoring System).
Results: 21 participants (mean age 48 years, 67% male) were studied across three sites. 81% of participants had mild AP and 19% had moderately severe AP. 24% were related to alcohol, 33% to biliary disease, 33% to hypertriglyceridemia and 14% to other etiologies. Technical success was 100%. There was one report of cold sensation related to the device and another report of pneumonia that was possibly related to the device. There were no unanticipated adverse device effects. Mean reductions in hematocrit (13.4%), BUN (19.7%), creatinine (6.5%), amylase (80.6%), and lipase (85.8%) were reported. PASS scores declined from a baseline mean of 146.1 to below 40 by 14 day follow up. Discussion: This FIH study provides preliminary evidence of safety and effectiveness and supports further clinical evaluation.
Disclosures:Bernardo Goecke: Arctx Medical – Investigator. Karina Carcamo: Arctx Medical – Co-investigator. Jose Vargas: Arctx Medical – Investigator. Jan Cubilla: Arctx Medical – Investigator. Walter Park: Amgen – Consultant. Arctx Medical – Advisory Committee/Board Member, Consultant, Stock Options. Capsovision – Consultant. mBiota – Advisory Committee/Board Member. Olympus – Consultant.
