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

• ClinicalTrials.gov Identifier: NCT03767881
• Recruitment Status: Completed
• First Posted: December 7, 2018
• Last Update Posted: April 1, 2022
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Tracking Information

• First Submitted Date: December 4, 2018
• First Posted Date: December 7, 2018
• Last Update Posted Date: April 1, 2022
• Actual Study Start Date: September 10, 2019
• Actual Primary Completion Date: December 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 5, 2018)

Resolution of Acute Cholecystitis [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 5, 2018)

Rate of re-interventions [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: December 5, 2018)

• Stent Patency [ Time Frame: Intraoperative (Stent placement through stent removal) ]
  Stent patency (ability to facilitate gallbladder drainage) defined indirectly as resolution of acute cholecystitis or, in the absence of resolution of acute cholecystitis, endoscopic observation of unobstructed AXIOSTM stent lumen
• Technical stent placement success [ Time Frame: Intraoperative (stent placement) ]
  Technical AXIOS stent placement success, defined as transmural placement of the AXIOSTM stent with confirmed stent patency via (i) drainage visualized through the stent or fluoroscopically, or (ii) ability to endoscopically observe the inner walls of the gallbladder through the AXIOSTM stent
• Technical stent removal success [ Time Frame: Intraoperative (stent removal) ]
  Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events
• Acute Cholecystitis recurrence [ Time Frame: Through study completion, up to 15 weeks ]
  Recurrence of acute cholecystitis and its management post AXIOS stent removal
• Number of cumulative hospital and ICU days [ Time Frame: Through study completion, up to 15 weeks ]
  Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
• Official Title: A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cholecystitis, Acute

Intervention

Device: 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.

Study Arms

Experimental: 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.

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 5, 2018): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2, 2021
• Actual Primary Completion Date: December 2, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, United States
• Removed Location Countries: Canada

Administrative Information

• NCT Number: NCT03767881
• Other Study ID Numbers: E7108
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Boston Scientific Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: Boston Scientific Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Shayan Irani, MBBS, MD; Virginia Mason Medical Center

• PRS Account: Boston Scientific Corporation
• Verification Date: March 2022