Bariatric Arterial Embolization for Morbid Obesity

Morbid Obesity Clinical Trial

— BAEMO  

Official title:

Bariatric Arterial Embolization for Morbid Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02786108
• Other study ID #: 2015ZDSYLL068.0
• Status: Recruiting
• Phase: Phase 3
• First received: May 25, 2016
• Last updated: June 5, 2016
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2016
• Source: Zhongda Hospital
• Contact: Zhibin Bai
• Email: baizhibin1004[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• left gastric artery embolization

Behavioral:
• healthy diet and exercise

Locations

Country	Name	City	State
China	Zhongda Hospital,Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	Unit of Measure: Percentage of excess weight loss [%EWL]. The body weight will be measured within 2-4h after breakfast.	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	No
Secondary	Blood pressure	The brachial artery blood pressure will be measured in the early hours of the morning and under the quiet situation. Unit of Measure: mmHg.	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	No
Secondary	Lipid Profile	Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	No
Secondary	Number of Patients with Adverse Events	Surgical complications and adverse events such as massive hemorrhage, femoral artery pseudoaneurysm, gastric mucosal ischemia and necrosis and gastric perforation, etc., will be documented.	post-op 30 days	Yes
Secondary	Ghrelin levels	Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	No
Secondary	Abdominal fat content	Abdominal fat content detected by MRI.	Baseline, post-op 1 month,6 months,12 months	No
Secondary	Leptin levels	Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	No
Secondary	Results of Gastroendoscopic Examination	Photos and clinical reports will be analyzed.	Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months	No
Secondary	Quality of Life Parameters Survey	N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.	12 months	No