Clinical Trial of EPASS With Hot AXIOS System (NCT05644951) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial of EPASS With Hot AXIOS System
Japan51 participantsStarted 2022-12-23
Plain-language summary
A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unresectable malignant duodenal obstruction confirmed by biopsy
* 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:
* GOO symptoms are not expected to improve after the index procedure
* 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 preg…