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Sleeve GastrectomyEMBOSLEEVENCT05710263

Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

A study testing bariatric embolization in people with Sleeve Gastrectomy and Morbid Obesity, run by Centre Hospitalier Universitaire, Amiens.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In patients with severe obesity, bariatric surgery provides consistent and long-term weight loss. BMI ≥50kg / m2 is an independent factor of increased morbidity / mortality in bariatric surgery compared with patients weighing less than 50 kg / m2 (1.2% and 0.8%) mainly due to technical difficulties. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bariatric embolization
Type of treatment
Surgery or procedure
How many people
0 participants
Where
No sites listed yet
Study dates
10 Jan 2023to 13 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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 ..)

About this study

In patients with severe obesity, bariatric surgery provides consistent and long-term weight loss. BMI ≥50kg / m2 is an independent factor of increased morbidity / mortality in bariatric surgery compared with patients weighing less than 50 kg / m2 (1.2% and 0.8%) mainly due to technical difficulties. Preoperative weight loss reduces this morbidity / mortality. Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss. The purpose of this study was to evaluate the safety and effectiveness of the association bariatric embolization before sleeve gastrectomy in super obese patients.

Being tested
bariatric embolization
Keywords
bariatric embolization, sleeve gastrectomy, super obese, left gastric artery, Morbid Obesity, bariatric surgery
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bariatric embolizationProcedure or surgery

    bariatric or left gastric artery embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NUmber of Adverse Events

    Measured: 12 months

Secondary outcomes (1)

  1. Weight Loss

    Unit of Measure: Percentage of excess weight loss

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start10 Jan 2023
  3. Primary completion13 Feb 2025
  4. Study completion13 Feb 2025

Why it stopped: no patient enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05710263
Sponsor's protocol ID
PI2019_843_0043
Acronym
EMBOSLEEVE
Status last verified
Jun 2026
First submitted
24 Jan 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing bariatric embolization in people with Sleeve Gastrectomy and Morbid Obesity, run by Centre Hospitalier Universitaire, Amiens.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NUmber of Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05710263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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