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

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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

Tracking Information
First Submitted Date  ICMJE December 4, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date September 17, 2021
Actual Study Start Date  ICMJE September 10, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cholecystitis, Acute
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT03767881
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shayan Irani, MBBS, MD Virginia Mason Medical Center
PRS Account Boston Scientific Corporation
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP