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

Primary Purpose

Cholecystitis, Acute

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis, Acute focused on measuring AXIOS, Acute Cholecystitis, Percutaneous Gallbladder Drainage, Cholecystitis, Gallbladder Drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver
  • Emory University School of Medicine
  • Parkview Medical Center
  • Mayo Clinic
  • Cleveland Clinic
  • Virginia Mason Medical Center
  • UZ Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

Arm Description

Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.

Outcomes

Primary Outcome Measures

Number of Days to Resolution of Acute Cholecystitis
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

Rate of Re-interventions
Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.

Full Information

First Posted
December 4, 2018
Last Updated
January 23, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03767881
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute
Keywords
AXIOS, Acute Cholecystitis, Percutaneous Gallbladder Drainage, Cholecystitis, Gallbladder Drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Arm Type
Experimental
Arm Description
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
Intervention Type
Device
Intervention Name(s)
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Intervention Description
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 Measure Information:
Title
Number of Days to Resolution of Acute Cholecystitis
Description
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.
Time Frame
Up to 15 weeks
Secondary Outcome Measure Information:
Title
Rate of Re-interventions
Description
Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.
Time Frame
Through study completion, Up to 15 weeks
Other Pre-specified Outcome Measures:
Title
Stent Patency
Description
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
Time Frame
Stent placement through stent removal, approximately 60 days
Title
Number of Participants With Successful Technical Stent Placement.
Description
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
Time Frame
Intraoperative (stent placement)
Title
Number of Participants With Successful Technical Stent Removal.
Description
Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events
Time Frame
Intraoperative (stent removal)
Title
Acute Cholecystitis Recurrence
Description
Recurrence of acute cholecystitis and its management post AXIOS stent removal
Time Frame
Through study completion, up to 15 weeks
Title
Number of Cumulative Hospital and ICU Days
Description
Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis
Time Frame
Through study completion, up to 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shayan Irani, MBBS, MD
Organizational Affiliation
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Parkview Medical Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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