Bariatric Arterial Embolization for Morbid Obesity (BAEMO)

Southeast University

Status and phase: Unknown; Phase 3

Conditions: Morbid Obesity

Treatments: Behavioral: healthy diet and exercise; Procedure: left gastric artery embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT02786108

2015ZDSYLL068.0

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of left gastric artery embolization(bariatric arterial embolization) for morbid obesity. When the target vessel is blocked, some of the body's signals for feeling hungry will be suppressed and lead to weight loss.

Although there are many ways to treat morbid obesity, surgery is currently the only effective method to be confirmed. But surgical treatment is likely to carry a high risk of treatment-related complications, such as fistula or intestinal obstruction, etc. This study is designed to help treat obesity using a method of transvascular interventional therapy, which is minimally invasive and non-surgical.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Body mass index (BMI) >30.

2. No history of gastrointestinal surgery.

3. Willing, able and mentally competent to provide written informed consent.

4. Suitable for protocol therapy as determined by the interventional radiology Investigator.

5. 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

6. Aged between18 and 65 years old.

7. More than one year's follow-up can be obtained reliably

Exclusion criteria

1. Prior history of gastric pancreatic, hepatic, and/or splenic surgery
2. Prior embolization to the stomach, spleen or liver
3. Prior or current history of peptic ulcer disease
4. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
5. Portal venous hypertension or cirrhosis
6. Less than 18 years or older than 65 years of age
7. Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute an estimated glomerular filtration rate of < 60 milliliters per minute
8. Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
9. Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
10. Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.
11. Patients currently taking or requiring chronic use of NSAID or steroid medications

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

left gastric artery embolization

Experimental group

Description:

Patients undergoing left gastric artery embolization

Treatment:

Procedure: left gastric artery embolization

healthy diet and exercise

Active Comparator group

Description:

Patients undergoing healthy diet and exercise

Treatment:

Behavioral: healthy diet and exercise