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

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

Primary Outcome

Resolution of Acute Cholecystitis

Secondary Outcome

 Rate of re-interventions

Condition

Cholecystitis, Acute

Intervention

AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

Study Arms / Comparison Groups

 AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

30

Start Date

September 10, 2019

Completion Date

March 2022

Primary Completion Date

October 2021

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shayan Irani, MBBS, MD, (978) 483-8856, [email protected]

Location Countries

Belgium

Location Countries

Belgium

NCT ID

NCT03767881

Organization ID

E7108

Responsible Party

Sponsor

Study Sponsor

Boston Scientific Corporation

Study Sponsor

Shayan Irani, MBBS, MD, Principal Investigator, Virginia Mason Medical Center

Verification Date

June 2020