Clinical Trial of EPASS With Hot AXIOS System
- Conditions
- Gastric Outlet Obstruction
- Registration Number
- NCT05644951
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Unresectable malignant duodenal obstruction confirmed by biopsy<br><br> - Eligible for endoscopic intervention<br><br> - GOOSS score of 0 or 1<br><br> - 18 years of age or older<br><br> - Willing and able to comply with the study procedures or legally authorized<br> representative (LAR) must provide written informed consent form (ICF) to participate<br> in the study<br><br>Exclusion Criteria:<br><br> - GOO symptoms are not expected to improve after the index procedure<br><br> - Life expectancy is about 3 months or less, which is not assumed applicable for<br> surgical GJ<br><br> - Prior metallic stent placement for GOO<br><br> - Contraindicated to surgery and general anesthesia<br><br> - Neoplasm invading the target site of puncture in gastric and/or jejunum<br><br> - Abnormal coagulation INR > 1.5 and not correctable (per the discretion of the<br> physician) or who require continuous complete anticoagulation<br><br> - Bleeding diathesis<br><br> - Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus,<br> stomach and duodenum that might preclude endoscopic drainage<br><br> - Presence of ileus caused by peritoneal carcinomatosis, or expected to present within<br> 30 days post procedure<br><br> - Intervening gastric varices or vessels at the target site of stent insertion<br><br> - Ascites that may interfere the safety of the index procedure<br><br> - Biliary tract obstruction requiring treatment at the same day of the index procedure<br><br> - Allergic to any of the device materials<br><br> - Contraindications to use of electrosurgical devices<br><br> - Pregnancy, breastfeeding or intending to become pregnant during the study period<br><br> - Subject is currently participating, or plans to participate in, another<br> investigational trial that may confound the results of this trial (unless written<br> approval is received from the study sponsor)<br><br> - Vulnerable subject<br><br> - Subject has other reason not to be eligible for this study per investigators'<br> discretion<br><br> - Guidewire doesn't cross the area of GOO<br><br> - EP-DB doesn't advance to the target site in jejunum<br><br> - The distance between the gastric wall and jejunal wall when visualized on ultrasound<br> after saline is introduced into the space between the two inflated balloons of EP-DB<br> is deemed about 2 cm or more
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GOOSS 3 rate without MAE
- Secondary Outcome Measures
Name Time Method