New balloon device aims to ease stomach blockages without surgery
NCT ID NCT07161856
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study compares a new balloon-assisted technique to the standard water-injection method for creating a stomach-to-intestine bypass in people with gastric outlet obstruction. The blockage, often caused by advanced cancer, leads to nausea, vomiting, and malnutrition. The new approach aims to shorten procedure time, reduce fluid use, and improve safety. About 272 adults who cannot have surgery or stents will take part across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- novel single-balloon-assisted device for EUS-guided gastroenterostomy
- What this could lead to
- If successful, this new technique could offer a safer, faster, and less invasive way to relieve gastric outlet obstruction, improving quality of life for patients who cannot have surgery.
- What could go wrong
- This is an early-stage trial with 272 participants, and the new device may not prove safer or more effective than the current method. The procedure still carries risks like bleeding or infection.
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 272 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 80 years
- 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: * Age ranges from 18 to 80 years old * GOO patients caused by all reasons (including benign diseases such as ulcers or malignant tumors) * Not suitable for or cannot tolerate surgical operations and endoscopic intestinal stent implantation * There are no absolute contraindications for EUS-GE * Signed informed consents Exclusion Criteria: * Pregnant and lactating women * Unable or refused to provide informed consents * Patients with cognitive impairment, aphasia, mental disorders, or other conditions that may affect the patient's cooperation * Patients with endoscopic contraindications, anesthesia contraindications, digestive tract perforation or abdominal cavity infection * The tumor invades the duodenum or the upper segment of the jejunum Individuals whom the investigator deems unsuitable for participation
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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 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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?