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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03767881
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cholecystitis, Acute Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. Acute Cholecystitis recurrence [ Time Frame: Through study completion, up to 15 weeks ]
    Recurrence of acute cholecystitis and its management post AXIOS stent removal

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767881


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Indiana
Parkview Medical Center
Fort Wayne, Indiana, United States, 46845
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Belgium
UZ Leuven
Leuven, Belgium, B-3000
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Shayan Irani, MBBS, MD Virginia Mason Medical Center
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03767881    
Other Study ID Numbers: E7108
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Boston Scientific Corporation:
AXIOS
Acute Cholecystitis
Percutaneous Gallbladder Drainage
Cholecystitis
Gallbladder Drainage
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases