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

Not Applicable

Completed

• Conditions: Cholecystitis, Acute
• Interventions: Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

• Registration Number: NCT03767881
• Lead Sponsor: Boston Scientific Corporation

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 gallbladder drainage.

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 AXIOS stent for up to 60 days indwell and 72 hour follow-up after stent removal.

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Study Start: 2019-09-10
• Primary Completion: 2021-12-02
• Study Completion: 2021-12-02
• Status Verified: 2022-11
• Results First Submitted: 2022-11-28
• Results First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Results First Posted: 2023-02-17
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System	AXIOS(TM) Stent and Electrocautery Enhanced Delivery System	Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.

Primary Outcome Measures

Name	Time	Method
Number of Days to Resolution of Acute Cholecystitis	Up to 15 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Parkview Medical Center; 🇺🇸 Fort Wayne, Indiana, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

UZ Leuven; 🇧🇪 Leuven, Belgium

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States