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
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic
ACTIVE_NOT_RECRUITING
Rochester
New York
New York Presbyterian/ Weill Cornell Medical Center
RECRUITING
New York
Pennsylvania
University of Pittsburg Medical Center
RECRUITING
Pittsburgh
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Brazil
Instituto do Cancer do Estado de Sao Paulo
NOT_YET_RECRUITING
São Paulo
Canada
McGill University Health Care
RECRUITING
Montreal
China
Shanghai Changhai Hospital
RECRUITING
Shanghai
India
Asian Institute of Gastroenterology
ACTIVE_NOT_RECRUITING
Hyderabad
Contact Information
Primary
Evelyne Ho, MPH, MBA
Evelyne.Ho@bsci.com
(978) 483-8856
Backup
William C Winter
william.winter@bsci.com
507-216-1063
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2027-03
Participants
Target number of participants: 67
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation