- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03525808
AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study
A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado, Denver
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Healthcare
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Health
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham & Women'S Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 22 and 75 years old
- Severe or moderately severe acute necrotizing pancreatitis, defined per the 2012 Revised Atlanta Classification.
WON resulting from necrotizing pancreatitis per contrast-enhanced CT with the following characteristics, per the 2012 Revised Atlanta Classification:
- Heterogeneous with liquid and non-liquid density with varying degrees of loculations (some may appear homogeneous)
- Well defined wall
- Location-intrapancreatic and/or extrapancreatic
- Infected WON or symptomatic sterile WON Note: WON-related symptoms may include: pain, fever, leukocytosis, failure to thrive or deterioration of overall heath score, gastric outlet obstruction (GOO), weight loss, biliary obstructive symptoms, systemic inflammatory response syndrome (SIRS), deteriorating organ function, chronic nausea, lethargy, and inability to eat or gain weight
- Imaging suggestive of greater than 30% necrotic material
- WON ≥ 6cm in size
- Eligible for endoscopic intervention
- Acceptable candidate for endoscopic transluminal drainage
- Patient understands the study requirements and the treatment procedures and provides written Informed Consent
- Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post imaging study
Exclusion Criteria:
- Pseudocyst
- Cystic neoplasm
- Untreated Pseudoaneurysm > 1cm within the WON
- More than one WON clearly separated and requiring drainage
- WONs that require dual modality interventions (endoscopic and percutaneous) from the beginning (i.e. deep paracolic space involvement that is inaccessible through the central drainage access)
- Prior surgical, interventional radiology or endoscopic procedures for the treatment of the WON
Abnormal coagulation:
- INR > 1.5 and not correctable
- presence of a bleeding disorder
- platelets < 50,000/mm3
- Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound)
- WON that poorly approximates the GI lumen (≥1cm away)
- Pericolic gutter necrosis
- Pelvic necrosis
- Prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient
- Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AXIOS
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
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Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Resolution of WON With Endoscopic Drainage
Time Frame: Up to 60 Days
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Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI
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Up to 60 Days
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AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events
Time Frame: Through study completion, average of 8 months
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AXIOS stent related or WON drainage procedure related serious adverse events
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Through study completion, average of 8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom Reduction
Time Frame: Through study completion, average of 8 months
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Reduction of WON-related clinical symptoms.
Note: WON-related symptoms as defined in Inclusion Criteria #4
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Through study completion, average of 8 months
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Technical Success
Time Frame: Intraoperative (Stent placement)
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Technical AXIOS stent placement success, defined as placement in desired location using endoscopic/EUS techniques per standard of practice. Technical AXIOS stent removal success, defined as ability to remove the AXIOS stent using an endoscopic snare or forceps or graspers without AXIOS stent removal related serious adverse events. |
Intraoperative (Stent placement)
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Drainage Procedural Time
Time Frame: Intraoperative (Stent placement)
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Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
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Intraoperative (Stent placement)
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Resolution of WON: Radiographic Resolution Evaluated by MRI or CT
Time Frame: Through study completion, average of 8 months
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Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal.
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Through study completion, average of 8 months
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Time to WON Resolution
Time Frame: Up to 60 Days
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Time to WON resolution using same definition as for primary endpoint, namely:
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Up to 60 Days
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WON Recurrence
Time Frame: Through study completion, average of 8 months
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Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.
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Through study completion, average of 8 months
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Stent Lumen Patency
Time Frame: Intraoperative (Stent placement through stent removal)
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Stent lumen patency, evaluated via imaging or direct visual inspection with endoscope, and defined as one or both of the following:
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Intraoperative (Stent placement through stent removal)
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Fluoroscopy
Time Frame: Intraoperative (Stent placement through stent removal)
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Fluoroscopy (time) per endoscopic procedure.
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Intraoperative (Stent placement through stent removal)
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Incidence of New Organ Failure
Time Frame: Up to 60 days
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Number of participants with new organ failure from drainage procedure to WON resolution.
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Up to 60 days
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Change in SF-12 Score
Time Frame: Difference from baseline to stent removal (up to 60 days) visit
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*Change* in Quality of Life score (SF-12 questionnaire) from *baseline to stent removal*.
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health.
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
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Difference from baseline to stent removal (up to 60 days) visit
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E7116
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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