Clinical Trial of EPASS with Hot AXIOS System

Launched by BOSTON SCIENTIFIC CORPORATION · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called EPASS (Endoscopic Ultrasound-guided Double-Balloon-Occluded Gastrojejunostomy Bypass) to help patients with gastric outlet obstruction caused by cancer. This condition makes it difficult for food to pass from the stomach to the intestine, and the trial aims to see if this new technique can safely create a bypass to improve patients' ability to eat and digest food.

To be eligible for the trial, participants must be at least 18 years old and have a specific type of blockage in the digestive tract that cannot be treated with surgery. They should also be able to complete the study procedures and provide consent. The trial is currently recruiting participants, and everyone involved can expect to undergo the EPASS procedure, along with regular follow-up assessments to monitor their health and the effectiveness of the treatment. It's important to know that not everyone will qualify for this study; certain health conditions or previous treatments may exclude them.

Gender

ALL

Eligibility criteria

• 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 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

Trial Officials