N/A
N=30
AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
Cholecystitis, Acute
Bottom Line
View on ClinicalTrials.gov: NCT03767881 ↗Enrolled (actual)
30
Serious AEs
53.3%
Results posted
Feb 2023
Primary outcome: Primary: Number of Days to Resolution of Acute Cholecystitis — 5.30 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AXIOS(TM) Stent and Electrocautery Enhanced Delivery System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days to Resolution of Acute Cholecystitis |
5.30 | — |
| SECONDARY Rate of Re-interventions |
5 | — |
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.
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 2.0 mg/dl (>177 μmol/liter)
- Hepatic - International normalized ratio >1.5
- Hematologic - Platelet count 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
Data sourced from ClinicalTrials.gov (NCT03767881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.