New stent aims to help cancer patients eat again without surgery
NCT ID NCT06174805
First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 5 times
Summary
This study tests a special stent placed using an endoscope to connect the stomach to the small intestine in people whose stomach is blocked by advanced cancer. The goal is to help them eat and drink more easily without major surgery. The study plans to enroll 67 participants and will check how safe and effective the stent is over 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AXIOS stent (a tube placed via endoscopy to connect the stomach to the small intestine)
- What this could lead to
- If successful, this could offer a less invasive way to help people with advanced cancer eat and drink again by relieving stomach blockages.
- What could go wrong
- This is a small, early study (67 people) and is currently suspended. The stent may cause serious side effects like infection or bleeding, and it may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 67 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Gastric outlet obstruction from unresectable malignant neoplasm 2. Eligible for endoscopic intervention 3. GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet 4. 18 years of age or older 5. 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 6. The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm Exclusion Criteria: 1. Patients with baseline ECOG \> 2 and/or Karnofsky Performance score \< 30 2. Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent 3. Abnormal coagulation INR \> 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation, and/or any underlying condition associated with high risk of bleeding 4. Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy 5. Multiple-level bowel obstruction downstream from the intended location of the EUS-guided bypass confirmed by radiography such as small bowel series or computed tomography 6. Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1.0 cm at the proposed site of AXIOSTM stent insertion 7. Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall 8. Ascites Grade ≥ 2 confirmed by cross-sectional imaging 9. Vessels located within a two-centimeter radius of the device insertion location 10. History of multiple abdominal surgeries and/or evidence of small bowel adhesions 11. Allergic to any of the device materials 12. Contraindications to use of electrical devices 13. Pregnancy 14. Prisoners and other vulnerable populations
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 6 countries. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asian Institute of Gastroenterology
Hyderabad, India
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-092, Brazil
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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McGill University Health Care
Montreal, H3Z 2E9, Canada
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New York Presbyterian/ Weill Cornell Medical Center
New York, New York, 10065, United States
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Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
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UZ Leuven
Leuven, Belgium
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University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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Virginia Mason Medical Center
Seattle, Washington, 98101, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a modified stomach bypass speed up recovery in advanced gastric cancer?
- New scope procedure vs. surgery: which unblocks the stomach faster?
- Magnets replace knives: new procedure eases stomach blockages
- New surgery aims to eater eating for stomach cancer patients
- New study pits two endoscopic techniques against each other for stomach blockage relief
- Which procedure best unblocks the stomach in pancreatic cancer?