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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05644951
Other study ID # E7127
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 23, 2022
Est. completion date July 31, 2025

Study information

Verified date May 2024
Source Boston Scientific Corporation
Contact Ryo Konishi
Phone +81368537500
Email JapanClinicalTrials@bsci.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 51
Est. completion date July 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hot AXIOS system used for EPASS
EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system

Locations

Country Name City State
Japan The University of Tokyo Hospital Bunkyo-Ku Tokyo
Japan Saitama Medical University International Medical Center Hidaka Saitama
Japan Cancer Institute Hospital of JFCR Koto-Ku Tokyo
Japan Aichi Cancer Center Hospital Nagoya Aichi
Japan Teine Keijinkai Hospital Sapporo Hokkaido
Japan Tokyo Medical University Hospital Shinjuku-Ku Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary GOOSS 3 rate without MAE GOOSS 3 rate without MAE 30 days post index-procedure
See also
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