Skip to main content
OpenTrials
Suspended

NCT Number: NCT06174805

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

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.

Why the study stopped: Sponsor Decision
Suspended

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Outlet Obstruction Digestive System Diseases Gastrointestinal Diseases Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven, Leuven, Belgium

Loading trial locations.

About this study

The study is a prospective multi-center, single -arm study with treatment of up to 67 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the AXIOS stent and up to 12 months follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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
  • The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Serious Adverse Events

    Time frame: Through study completion, an average of 1 year

    The proportion of subjects with one or more AXIOS stent related or AXIOS endoscopic and/or study procedure related serious adverse events through 30 days post stent placement.

  2. Technical Success

    Time frame: During the procedure

    The proportion of subjects that demonstrate technical 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.

  3. Primary Effectiveness Endpoint

    Time frame: through 14 days after procedure

    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.

Other outcomes

  1. 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

    Time frame: Through study completion, an average of 1 year

    A patient undergoing reintervention for GOO is considered a failure of clinical success

  2. Time to resumption of oral intake after stent placement.

    Time frame: Immediately after the procedure

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

    Time frame: Immediately after the procedure

  4. Change in Quality-of-Life score (SF-12 questionnaire) from baseline to 30 days, 3 months, 6 months, and 12 months

    Time frame: Through study completion, an average of 1 year

  5. Incidence of Device Deficiencies

    Time frame: Immediately after the procedure

    Including but not limited to stent migration/misplacement, stent occlusion, leakage at site of stent placement.

  6. Incidence of Reintervention for GOO

    Time frame: Immediately after the procedure

    defined as need for repeat treatment for persistent or recurrent GOO symptoms

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2023
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.