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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cholecystitis, Acute

Intervention / Treatment
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* Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System


Participation Criteria
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Eligibility Criteria
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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: 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 patient or legally authorized representative (LAR) must 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 Patients with abnormal coagulation or who require ongoing complete anticoagulation Bleeding diathesis History of surgical treatment of acute cholecystitis (e.g. cholecystectomy) Patients with a current percutaneous drainage Patients with a history of percutaneous gallbladder drainage without AC free period following percutaneous drainage removal 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System<br>Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis. | Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System<br>* Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days to Resolution of Acute Cholecystitis | Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category. | Up to 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Re-interventions | Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement. | Through study completion, Up to 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AXIOS, Acute Cholecystitis, Percutaneous Gallbladder Drainage, Cholecystitis, Gallbladder Drainage