AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

NCT06174805 | Suspended DMC FDA Device

• 1 other identifier: E7152
• Study Type: interventional
• Target: 67
• Locations: 6 countries
• Sites: 10

Brief Summary

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

Keywords

GOO; Gastric Outlet Obstruction; AXIOS; Gastroenterostomy

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoint

  AXIOS stent related or AXIOS endoscopic and/or study procedure related serious adverse events through 30 days post stent placement.

  Through study completion, an average of 1 year

• Primary Technical Success Endpoint

  Successful stent placement, defined as transmural placement of the AXIOS stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOS stent lumen. Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. Note: Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement.

  During the procedure

• Primary Effectiveness Endpoint

  Clinical Success defined as improvement of Gastric Outlet Obstruction Score (GOOS)by 1 point from baseline to any point during 14 days after AXIOS stent placement and GOOS remaining at 1 or more without the need for reintervention due to loss of stent function at 30 days post-index procedure or death, whichever comes first.

  through 14 days after procedure

Other Outcomes (6)

• Clinical success over time defined as improvement of GOOS by 1 point from baseline at any time during 14 days after AXIOS stent placement and GOOS remaining at 1 or more. This endpoint will be evaluated at 3 months, 6 months, and 12 months

  Through study completion, an average of 1 year

• Time to resumption of oral intake after stent placement.

  Immediately after the procedure

• Time to start or resume chemotherapy after AXIOSTM stent placement (where applicable)

  Immediately after the procedure

Study Arms (1)

AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

EXPERIMENTAL

Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm

Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

Interventions

AXIOS(TM) Stent and Electrocautery Enhanced Delivery System DEVICE

Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm

AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

Eligibility Criteria

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

You may qualify if:

• Gastric outlet obstruction from unresectable malignant neoplasm
• Eligible for endoscopic intervention
• GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet
• 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
• The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm

You may not qualify if:

• Patients with baseline ECOG \> 2 and/or Karnofsky Performance score \< 30
• Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
• 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
• Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
• 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
• 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
• Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
• Ascites Grade ≥ 2 confirmed by cross-sectional imaging
• Vessels located within a two-centimeter radius of the device insertion location
• History of multiple abdominal surgeries and/or evidence of small bowel adhesions
• Allergic to any of the device materials
• Contraindications to use of electrical devices
• Pregnancy
• Prisoners and other vulnerable populations

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (10)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York Presbyterian/ Weill Cornell Medical Center

New York, New York, 10065, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

UZ Leuven

Leuven, Belgium

Location

Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246-092, Brazil

Location

McGill University Health Care

Montreal, H3Z 2E9, Canada

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Asian Institute of Gastroenterology

Hyderabad, India

Location

MeSH Terms

Conditions

Gastric Outlet Obstruction

Interventions

Stents

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Shayan Irani, MBBS, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 18, 2023
• Study Start: February 11, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

IN (1); BR (1); BE (1); CA (1); CN (1); US (5)