Gastric Outlet ObstructionPASSAGENCT05644951
Clinical Trial of EPASS With Hot AXIOS System
A study testing Hot AXIOS system used for EPASS in people with Gastric Outlet Obstruction, run by Boston Scientific Corporation at 6 sites in Japan.
Trial summary
A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Outlet Obstruction
- What is being tested?
- Hot AXIOS system used for EPASS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 6 sitesJapan
- Study dates
- 23 Dec 2022to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable malignant duodenal obstruction confirmed by biopsy
- Eligible for endoscopic intervention
- GOOSS score of 0 or 1
- 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
Who cannot join
- GOO symptoms are not expected to improve after the index procedure
- Life expectancy is about 3 months or less, which is not assumed applicable for surgical GJ
- Prior metallic stent placement for GOO
- Contraindicated to surgery and general anesthesia
- Neoplasm invading the target site of puncture in gastric and/or jejunum
- Abnormal coagulation INR > 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation
Show all 21Show fewer
- Bleeding diathesis
- Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage
- Presence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedure
- Intervening gastric varices or vessels at the target site of stent insertion
- Ascites that may interfere the safety of the index procedure
- Biliary tract obstruction requiring treatment at the same day of the index procedure
- Allergic to any of the device materials
- Contraindications to use of electrosurgical devices
- Pregnancy, breastfeeding or intending to become pregnant during the study period
- Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the study sponsor)
- Vulnerable subject
- Subject has other reason not to be eligible for this study per investigators' discretion
- Guidewire doesn't cross the area of GOO
- EP-DB doesn't advance to the target site in jejunum
- The distance between the gastric wall and jejunal wall when visualized on ultrasound after saline is introduced into the space between the two inflated balloons of EP-DB is deemed about 2 cm or more
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, 1130033
Saitama Medical University International Medical Center
Hidaka, Saitama, 3501241
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, 1350063
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 4648681
Teine Keijinkai Hospital
Sapporo, Hokkaido, 0060829
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, 1600023
About this study
Official title: A Prospective, Multi-center, Single-arm Study for Unresectable Malignant Gastric Outlet Obstruction With EUS-guided Double-balloon-occluded Gastrojejunostomy Bypass
A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)
Read the detailed description
Primary objective is to investigate the safety and effectiveness of the AXIOS™ lumen-apposing Metal Stent used in the EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for the management of symptoms associated with gastric outlet obstruction (GOO) secondary to malignant unresectable neoplasm.
Primary Endpoint is GOOSS 3 rate without MAE at 30 days post procedure.
- Conditions
- Gastric Outlet Obstruction
- Being tested
- Hot AXIOS system used for EPASS
- Medical subject headings
- Gastric Outlet Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot AXIOS system used for EPASSDevice
EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system
| Study group | Role | What they receive |
|---|---|---|
| Hot AXIOS system | Experimental | Hot AXIOS system (20 mm diameter stent) Receives: Device: Hot AXIOS system used for EPASS |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOOSS 3 rate without MAE
GOOSS 3 rate without MAE
Measured: 30 days post index-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start23 Dec 2022
- Primary completion5 Dec 2024
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Outlet ObstructionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takao Itoi, MD, Principal investigator, Tokyo Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644951
- Sponsor's protocol ID
- E7127
- Acronym
- PASSAGE
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The anonymized data and study protocol for this clinical trial may be made available to other researchers in accordance with Boston Scientific Data Sharing Policy: (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-arm Study for Unresectable Malignant Gastric Outlet Obstruction With EUS-guided Double-balloon-occluded Gastrojejunostomy Bypass
- ClinicalTrials.gov ID
- NCT05644951
- Acronym / sponsor ID
- PASSAGE / E7127
- Conditions
- Gastric Outlet Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)
Detailed description
Primary objective is to investigate the safety and effectiveness of the AXIOS™ lumen-apposing Metal Stent used in the EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for the management of symptoms associated with gastric outlet obstruction (GOO) secondary to malignant unresectable neoplasm.
Primary Endpoint is GOOSS 3 rate without MAE at 30 days post procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hot AXIOS system | Experimental | Device: Hot AXIOS system used for EPASSHot AXIOS system (20 mm diameter stent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unresectable malignant duodenal obstruction confirmed by biopsy
- Eligible for endoscopic intervention
- GOOSS score of 0 or 1
- 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
Key exclusion criteria (21 listed)
- GOO symptoms are not expected to improve after the index procedure
- Life expectancy is about 3 months or less, which is not assumed applicable for surgical GJ
- Prior metallic stent placement for GOO
- Contraindicated to surgery and general anesthesia
- Neoplasm invading the target site of puncture in gastric and/or jejunum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot AXIOS system used for EPASSEUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system | Device | Hot AXIOS system |
Primary outcome
GOOSS 3 rate without MAE
Time frame: 30 days post index-procedure
GOOSS 3 rate without MAE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Undecided. The anonymized data and study protocol for this clinical trial may be made available to other researchers in accordance with Boston Scientific Data Sharing Policy: (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takao Itoi, MD principal investigator
Tokyo Medical University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot AXIOS system used for EPASS in people with Gastric Outlet Obstruction, run by Boston Scientific Corporation at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GOOSS 3 rate without MAE (time frame: 30 days post index-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.