Clinical Trials

Inclusion Criteria:

• Patient requiring intervention for the management of symptoms associated with acute cholecystitis.
• Patients referred for percutaneous drainage of the gallbladder who are not surgical candidates because of advanced age, anesthetic risk, significant co-morbidities and/or overall health.
• Eligible for endoscopic intervention.
• Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines [3]: -AC Grade I (mild) defined as acute cholecystitis in an otherwise healthy patient with mild local inflammatory changes and without organ dysfunction. Criteria for grade II or III not met. -AC Grade II (moderate) defined by any one of the following characteristics -Leukocytosis (>18,000 cells per mm3) -Palpable, tender mass in right upper quadrant -Symptom duration >72 hours -Marked local inflammation (gangrenous or emphysematous cholecystitis, pericholecystic or hepatic abscess, biliary peritonitis).
• Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion.
• 18 years of age or older.
• Willing and able to comply with the study procedures and provide written informed consent form (ICF) to participate in the study. 

Exclusion Criteria:

• AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of the following systems: -Cardiovascular - Hypotension requiring administration of ≥5μg/kg/min of dopamine or any dose of norepinephrine -Neurologic - decreased level of consciousness -Respiratory - PaO2/FiO2 <300 -Renal - Oliguria and Creatinine >2.0 mg/dl (>177 μmol/liter) -Hepatic - International normalized ratio >1.5 -Hematologic - Platelet count <100,000/mm3.
• Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic gallbladder.
• Hepatic abscess.
• Ascites.
• Advanced liver disease.
• Subjects with abnormal coagulation or who require ongoing complete anticoagulation.
• Bleeding diathesis.
• Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum that might preclude endoscopic drainage.
• Prior surgical, interventional radiology or endoscopic procedures for the treatment of acute cholecystitis.
• Distance between gallbladder wall and duodenal or gastric wall > 1cm by US (ultrasound) at the time of drainage.
• Patients with intervening gastric varices or vessels within a one centimeter radius of the device insertion location.
• Patients that have allergies or are sensitive to any of the device materials.
• Patients with contraindications to use of electrical devices.
• Pregnancy.
• Prisoners and other vulnerable populations.