AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

August 6, 2026 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven
  • Brazil
      • São Paulo, Brazil, 01246-092
        • Instituto do Cancer do Estado de Sao Paulo
  • Canada
      • Montreal, Canada, H3Z 2E9
        • McGill University Health Care
  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Shanghai Changhai Hospital
  • India
      • Hyderabad, India
        • Asian Institute of Gastroenterology
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10065
        • New York Presbyterian/ Weill Cornell Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburg Medical Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
through 14 days after procedure
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.
Through study completion, an average of 1 year
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.
During the procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to resumption of oral intake after stent placement.
Time Frame: Immediately after the procedure
Immediately after the procedure
Time to start or resume chemotherapy after AXIOSTM stent placement (where applicable)
Time Frame: Immediately after the procedure
Immediately after the procedure
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
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
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.
Immediately after the procedure
Incidence of Reintervention for GOO
Time Frame: Immediately after the procedure
defined as need for repeat treatment for persistent or recurrent GOO symptoms
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shayan Irani, MBBS, MD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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