Pfizer COVID-19 vaccine appointments are available to our patients. Sign up for Connect today to schedule your vaccination.

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

Clinical Trial Details

This study is for female and male patients who are 18 years of age and older and have Gastric Outlet Obstruction (GOO). GOO is the inability of the stomach to empty its contents into the duodenum.

This study is taking place to determine if a newer type of metal stent with a plastic covering called the AXIOSTM stent, is safe and effective in alleviating the symptoms of GOO. AXIOSTM stent is an investigational device which means it is not currently approved by the U.S. Food and Drug Administration (FDA). 
   
If a patient is eligible and willing to participate, we will collect information about the subject’s GOO related symptoms, basic questions about quality of life and daily activities. There will be imaging done before, during, and after the stent placement procedure. There are approximately 10 study visit(s).

Participants will be compensated for completed study visits.

Key Eligibility: 
  1. Men and women who are 18 years of age and older.
  2. Individuals who have been diagnosed with Gastric Outlet Obstruction.

Detailed eligibility will be reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

GI/ Hepatology
646-962-5483
GIHepResearch@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2401026976

ClinicalTrials.gov:

NCT06174805

Sponsor:

AXIOS GE Project # E7152

Status

Open to Enrollment

Age Group

Adult

Sponsor