NCT03767881

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 17, 2023

Completed
Last Updated

February 17, 2023

Status Verified

November 1, 2022

Enrollment Period

2.2 years

First QC Date

December 4, 2018

Results QC Date

November 28, 2022

Last Update Submit

January 23, 2023

Conditions

Cholecystitis, Acute

Keywords

AXIOSAcute CholecystitisPercutaneous Gallbladder DrainageCholecystitisGallbladder Drainage

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 15 weeks

Secondary Outcomes (1)

  • Rate of Re-interventions

    Through study completion, Up to 15 weeks

Other Outcomes (5)

  • Stent Patency

    Stent placement through stent removal, approximately 60 days

  • Number of Participants With Successful Technical Stent Placement.

    Intraoperative (stent placement)

  • Number of Participants With Successful Technical Stent Removal.

    Intraoperative (stent removal)

  • +2 more other outcomes

Study Arms (1)

AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

EXPERIMENTAL

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

Interventions

AXIOS(TM) Stent and Electrocautery Enhanced Delivery SystemDEVICE

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

AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Parkview Medical Center

Fort Wayne, Indiana, 46845, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

UZ Leuven

Leuven, B-3000, Belgium

Location

Related Publications (1)

  • Irani SS, Sharma NR, Storm AC, Shah RJ, Chahal P, Willingham FF, Swanstrom L, Baron TH, Shlomovitz E, Kozarek RA, Peetermans JA, McMullen E, Ho E, van der Merwe SW. Endoscopic Ultrasound-guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis: A Prospective Multicenter Trial. Ann Surg. 2023 Sep 1;278(3):e556-e562. doi: 10.1097/SLA.0000000000005784. Epub 2022 Dec 20.

    PMID: 36537290DERIVED

MeSH Terms

Conditions

Cholecystitis, AcuteCholecystitis

Interventions

Stents

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Results Point of Contact

Title
Evelyne Ho, Clinical Project Manager
Organization
Boston Scientific
Evelyne.ho@bsci.com
1-978-483-8856

Study Officials

  • Shayan Irani, MBBS, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 7, 2018

Study Start

September 10, 2019

Primary Completion

December 2, 2021

Study Completion

December 2, 2021

Last Updated

February 17, 2023

Results First Posted

February 17, 2023

Record last verified: 2022-11

Locations

US(6)BE(1)