AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

Description

To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.

Conditions

Gastric Outlet Obstruction

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Study Overview

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Study Details

Study overview

To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.

A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy With Lumen-Apposing Metal Stent for Gastric Outlet Obstruction From Malignant Unresectable Disease

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

Condition
Gastric Outlet Obstruction
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

New York

New York Presbyterian/ Weill Cornell Medical Center, New York, New York, United States, 10065

Pittsburgh

University of Pittsburg Medical Center, Pittsburgh, Pennsylvania, United States, 15213

Seattle

Virginia Mason Medical Center, Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Gastric outlet obstruction from unresectable malignant neoplasm
  • 2. Eligible for endoscopic intervention
  • 3. GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet
  • 4. 18 years of age or older
  • 5. 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
  • 6. The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm
  • 1. Patients with baseline ECOG \> 2 and/or Karnofsky Performance score \< 30
  • 2. Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
  • 3. Abnormal coagulation INR \> 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation, and/or any underlying condition associated with high risk of bleeding
  • 4. Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
  • 5. Multiple-level bowel obstruction downstream from the intended location of the EUS- guided bypass confirmed by radiography such as small bowel series or computed tomography
  • 6. Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than than 1.0 at the proposed site of AXIOSTM stent insertion
  • 7. Gastric varices located within a 3.5-4 cm of the device insertion location on the gastric wall
  • 8. Ascites Grade ≥ 2 confirmed by cross-sectional imaging
  • 9. Vessels located within 3.5-4 cm of the pathway from the device insertion location on the gastric wall to the device insertion location of the small bowel wall
  • 10. History of multiple abdominal surgeries and/or evidence of small bowel adhesions
  • 11. Allergic to any of the device materials
  • 12. Contraindications to use of electrical devices
  • 13. Pregnancy
  • 14. Prisoners and other vulnerable populations

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Scientific Corporation,

Shayan Irani, MBBS, MD, PRINCIPAL_INVESTIGATOR, Virginia Mason Medical Center

Study Record Dates

2027-03