AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE

A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage

To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced Delivery System in the management of symptoms of acute cholecystitis as an alternative to percutaneous gallbladder drainage.

This study is a prospective, single arm, multi center trial. Treatment of up to 30 patients will take place at up to 9 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days indwell and 72 hour follow-up after stent removal.

Inclusion Criteria:

1. Patient requiring intervention for the management of symptoms associated with acute cholecystitis

2. 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

3. Eligible for endoscopic intervention

4. Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines:

   • 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)

5. Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion

6. 18 years of age or older

7. Willing and able to comply with the study procedures and patient or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study

Exclusion Criteria:

1. 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

2. Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic gallbladder

3. Hepatic abscess

4. Ascites

5. Patients with abnormal coagulation or who require ongoing complete anticoagulation

6. Bleeding diathesis

7. History of surgical treatment of acute cholecystitis (e.g. cholecystectomy)

8. Patients with a current percutaneous drainage

9. Patients with a history of percutaneous gallbladder drainage without AC free period following percutaneous drainage removal

10. Distance between gallbladder wall and duodenal or gastric wall > 1cm by US (ultrasound) at the time of drainage

11. Patients with intervening gastric varices or vessels within a one centimeter radius of the device insertion location

12. Patients that have allergies or are sensitive to any of the device materials

13. Patients with contraindications to use of electrical devices

14. Pregnancy

15. Prisoners and other vulnerable populations