Weight-loss surgery prep trial pulled before it even started
NCT ID NCT05710263
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if blocking blood vessels to part of the stomach (bariatric embolization) could help super obese patients lose weight before sleeve gastrectomy surgery, potentially lowering surgical risks. It planned to enroll patients with a BMI over 50 and at least three risk factors. However, the trial was withdrawn before any participants were enrolled, so no data were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bariatric embolization (blocking blood vessels to part of the stomach)
- What this could lead to
- If it had worked, this could have pointed toward a safer way to help super obese patients lose weight before surgery, reducing surgical risks.
- What could go wrong
- The trial was withdrawn before any patients enrolled, so no results exist. The approach is experimental and carries risks like bleeding or infection from the embolization procedure.
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
-
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.
- Started
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Jan 2023
- Finished
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Feb 2025
- Lead sponsor
-
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 years and older
- Sex
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Anyone
- Healthy volunteers
-
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: * Willing, able and mentally competent to provide written informed consent. * Body mass index (BMI) \>50kg/m². * 3 risk factors (De Maria et al) among: hypertension, male gender, age\>45, risk of pulmonary embolism * Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography. * Adequate hematological, hepatic and renal function as follows: Hematological Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L INR \<1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR \> 60ml/min.1.73m2 * Aged 18 years or older. * Patient who is going to be operated by sleeve gastrectomy Exclusion Criteria: * Prior history of gastric pancreatic, hepatic, and/or splenic surgery * Prior radiation to the upper abdomen * Prior embolization to the stomach, spleen or liver * Portal venous hypertension * Prior or current history of peptic ulcer disease * Significant risk factors for peptic ulcer disease including daily NSAID use and smoking. * Active H. Pylori infection * Weight greater than 240 kg * Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of \< 60 milliliters per minute * Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease. Pregnancy * ASA Class 4 or 5 (very high risk surgical candidates: class 4= incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study will be excluded from participation. This exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects. * History of Inflammatory Bowel Disease * Cirrhosis * Known history of allergy to iodinated contrast media * Contraindications to use Embosphere (ex:known allergy to gelatin ..)
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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