SUSPENDED

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

Conditions

Gastric Outlet Obstruction GOO AXIOS Gastroenterostomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-11

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT06174805

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 1.0 cm at the proposed site of AXIOSTM stent insertion 7. Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall 8. Ascites Grade ≥ 2 confirmed by cross-sectional imaging 9. Vessels located within a two-centimeter radius of the device insertion location 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

Inclusion Criteria

Exclusion 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 1.0 cm at the proposed site of AXIOSTM stent insertion
7. Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
8. Ascites Grade ≥ 2 confirmed by cross-sectional imaging
9. Vessels located within a two-centimeter radius of the device insertion location
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

Contacts and Locations

Principal Investigator

Shayan Irani, MBBS, MD

PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

New York Presbyterian/ Weill Cornell Medical Center

New York, New York, 10065

United States

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Virginia Mason Medical Center

Seattle, Washington, 98101

United States

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-11

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-02-11

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

GOO
Gastric Outlet Obstruction
AXIOS
Gastroenterostomy

Additional Relevant MeSH Terms

Gastric Outlet Obstruction