Clinical Trial of EPASS With Hot AXIOS System

NCT05644951 | Completed

• 1 other identifier: E7127
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 6

Brief Summary

A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)

Conditions

Gastric Outlet Obstruction

Outcome Measures

Primary Outcomes (1)

• GOOSS 3 rate without MAE

  GOOSS 3 rate without MAE

  30 days post index-procedure

Study Arms (1)

Hot AXIOS system

EXPERIMENTAL

Hot AXIOS system (20 mm diameter stent)

Device: Hot AXIOS system used for EPASS

Interventions

Hot AXIOS system used for EPASS DEVICE

EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system

Hot AXIOS system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable malignant duodenal obstruction confirmed by biopsy
• Eligible for endoscopic intervention
• GOOSS score of 0 or 1
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (6)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 4648681, Japan

Location

Teine Keijinkai Hospital

Sapporo, Hokkaido, 0060829, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, 3501241, Japan

Location

The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, 1130033, Japan

Location

Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, 1350063, Japan

Location

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, 1600023, Japan

Location

MeSH Terms

Conditions

Gastric Outlet Obstruction

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Takao Itoi, MD

  Tokyo Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: December 23, 2022
• Primary Completion: December 5, 2024
• Study Completion: August 29, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

JP (6)