Status:
COMPLETED
AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Cholecystitis, Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 gallbla...
Detailed Description
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 AXI...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03767881
Start Date
September 10 2019
End Date
December 2 2021
Last Update
February 17 2023
Active Locations (7)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
3
Parkview Medical Center
Fort Wayne, Indiana, United States, 46845
4
Mayo Clinic
Rochester, Minnesota, United States, 55905