Cholecystitis, AcuteNCT03767881
AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
A study testing AXIOS(TM) Stent and Electrocautery Enhanced Delivery System in people with Cholecystitis, Acute, run by Boston Scientific Corporation at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute
- What is being tested?
- AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 10 Sep 2019to 2 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
Cleveland Clinic
Cleveland, Ohio, 44195
Parkview Medical Center
Fort Wayne, Indiana, 46845
Mayo Clinic
Rochester, Minnesota, 55905
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
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.
Read the 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.
- Conditions
- Cholecystitis, Acute
- Being tested
- AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
- Keywords
- AXIOS, Acute Cholecystitis, Percutaneous Gallbladder Drainage, Cholecystitis, Gallbladder Drainage
- Medical subject headings
- Cholecystitis, Acute, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 weeks
Secondary outcomes (1)
Rate of Re-interventions
Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.
Measured: Through study completion, Up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start10 Sep 2019
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shayan Irani, MBBS, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767881
- Sponsor's protocol ID
- E7108
- Status last verified
- Nov 2022
- First submitted
- 4 Dec 2018
- Last updated
- 17 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 36537290
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
- ClinicalTrials.gov ID
- NCT03767881
- Acronym / sponsor ID
- E7108
- Conditions
- Cholecystitis, Acute
- Keywords
- AXIOS, Acute Cholecystitis, Percutaneous Gallbladder Drainage, Cholecystitis, Gallbladder Drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Posted 17 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Experimental | Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery SystemPatients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion
Key exclusion criteria (21 listed)
- AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of the following systems:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery SystemPatients 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 |
Primary outcome
Number of Days to 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.
1 secondary outcome
Rate of Re-interventions
Time frame: Through study completion, Up to 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36537290Irani 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cholecystitis, Acute
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
Cholecystitis, Acute, Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shayan Irani, MBBS, MD principal investigator
Virginia Mason Medical Center
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AXIOS(TM) Stent and Electrocautery Enhanced Delivery System in people with Cholecystitis, Acute, run by Boston Scientific Corporation at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days to Resolution of Acute Cholecystitis (time frame: Up to 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.