Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-25 @ 12:21 AM
Study NCT ID:
NCT05644951
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2022-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of EPASS With Hot AXIOS System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017219', 'term': 'Gastric Outlet Obstruction'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GOOSS 3 rate without MAE', 'timeFrame': '30 days post index-procedure', 'description': 'GOOSS 3 rate without MAE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Outlet Obstruction']}, 'descriptionModule': {'briefSummary': 'A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)', 'detailedDescription': '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.\n\nPrimary Endpoint is GOOSS 3 rate without MAE at 30 days post procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Unresectable malignant duodenal obstruction confirmed by biopsy\n* Eligible for endoscopic intervention\n* GOOSS score of 0 or 1\n* 18 years of age or older\n* 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\n\nExclusion Criteria:\n\n* GOO symptoms are not expected to improve after the index procedure\n* Life expectancy is about 3 months or less, which is not assumed applicable for surgical GJ\n* Prior metallic stent placement for GOO\n* Contraindicated to surgery and general anesthesia\n* Neoplasm invading the target site of puncture in gastric and/or jejunum\n* Abnormal coagulation INR \\> 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation\n* Bleeding diathesis\n* Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage\n* Presence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedure\n* Intervening gastric varices or vessels at the target site of stent insertion\n* Ascites that may interfere the safety of the index procedure\n* Biliary tract obstruction requiring treatment at the same day of the index procedure\n* Allergic to any of the device materials\n* Contraindications to use of electrosurgical devices\n* Pregnancy, breastfeeding or intending to become pregnant during the study period\n* 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)\n* Vulnerable subject\n* Subject has other reason not to be eligible for this study per investigators' discretion\n* Guidewire doesn't cross the area of GOO\n* EP-DB doesn't advance to the target site in jejunum\n* 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"}, 'identificationModule': {'nctId': 'NCT05644951', 'acronym': 'PASSAGE', 'briefTitle': 'Clinical Trial of EPASS With Hot AXIOS System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'A Prospective, Multi-center, Single-arm Study for Unresectable Malignant Gastric Outlet Obstruction With EUS-guided Double-balloon-occluded Gastrojejunostomy Bypass', 'orgStudyIdInfo': {'id': 'E7127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hot AXIOS system', 'description': 'Hot AXIOS system (20 mm diameter stent)', 'interventionNames': ['Device: Hot AXIOS system used for EPASS']}], 'interventions': [{'name': 'Hot AXIOS system used for EPASS', 'type': 'DEVICE', 'description': 'EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system', 'armGroupLabels': ['Hot AXIOS system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4648681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Cancer Center Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '0060829', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Teine Keijinkai Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '3501241', 'city': 'Hidaka', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University International Medical Center', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}, {'zip': '1130033', 'city': 'Bunkyō-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The University of Tokyo Hospital'}, {'zip': '1350063', 'city': 'Koto-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Cancer Institute Hospital of JFCR'}, {'zip': '1600023', 'city': 'Shinjuku-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical University Hospital'}], 'overallOfficials': [{'name': 'Takao Itoi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tokyo Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}