Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2022-12-23
2025-08-29
Brief Summary
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Detailed Description
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Primary Endpoint is GOOSS 3 rate without MAE at 30 days post procedure.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Hot AXIOS system
Hot AXIOS system (20 mm diameter stent)
Hot AXIOS system used for EPASS
EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system
Interventions
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Hot AXIOS system used for EPASS
EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system
Eligibility Criteria
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Inclusion Criteria
* Eligible for endoscopic intervention
* GOOSS score of 0 or 1
* 18 years of age or older
* Willing and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study
Exclusion Criteria
* Life expectancy is about 3 months or less, which is not assumed applicable for surgical GJ
* Prior metallic stent placement for GOO
* Contraindicated to surgery and general anesthesia
* Neoplasm invading the target site of puncture in gastric and/or jejunum
* Abnormal coagulation INR \> 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation
* Bleeding diathesis
* Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage
* Presence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedure
* Intervening gastric varices or vessels at the target site of stent insertion
* Ascites that may interfere the safety of the index procedure
* Biliary tract obstruction requiring treatment at the same day of the index procedure
* Allergic to any of the device materials
* Contraindications to use of electrosurgical devices
* Pregnancy, breastfeeding or intending to become pregnant during the study period
* Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the study sponsor)
* Vulnerable subject
* Subject has other reason not to be eligible for this study per investigators' discretion
* Guidewire doesn't cross the area of GOO
* EP-DB doesn't advance to the target site in jejunum
* The distance between the gastric wall and jejunal wall when visualized on ultrasound after saline is introduced into the space between the two inflated balloons of EP-DB is deemed about 2 cm or more
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Takao Itoi, MD
Role: PRINCIPAL_INVESTIGATOR
Tokyo Medical University Hospital
Locations
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Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Teine Keijinkai Hospital
Sapporo, Hokkaido, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
Countries
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Other Identifiers
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E7127
Identifier Type: -
Identifier Source: org_study_id
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