Bariatric Arterial Embolization for Morbid Obesity (BAEMO)
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|ClinicalTrials.gov Identifier: NCT02786108|
Recruitment Status : Unknown
Verified June 2016 by Gao-jun Teng, Zhongda Hospital.
Recruitment status was: Recruiting
First Posted : May 30, 2016
Last Update Posted : June 7, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Procedure: left gastric artery embolization Behavioral: healthy diet and exercise||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bariatric Arterial Embolization for Morbid Obesity|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||May 2018|
Experimental: left gastric artery embolization
Patients undergoing left gastric artery embolization
Procedure: left gastric artery embolization
Active Comparator: healthy diet and exercise
Patients undergoing healthy diet and exercise
Behavioral: healthy diet and exercise
- Weight Loss [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]Unit of Measure: Percentage of excess weight loss [%EWL]. The body weight will be measured within 2-4h after breakfast.
- Blood pressure [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]The brachial artery blood pressure will be measured in the early hours of the morning and under the quiet situation. Unit of Measure: mmHg.
- Lipid Profile [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.
- Number of Patients with Adverse Events [ Time Frame: post-op 30 days ]Surgical complications and adverse events such as massive hemorrhage, femoral artery pseudoaneurysm, gastric mucosal ischemia and necrosis and gastric perforation, etc., will be documented.
- Ghrelin levels [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.
- Abdominal fat content [ Time Frame: Baseline, post-op 1 month,6 months,12 months ]Abdominal fat content detected by MRI.
- Leptin levels [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.
- Results of Gastroendoscopic Examination [ Time Frame: Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months ]Photos and clinical reports will be analyzed.
- Quality of Life Parameters Survey [ Time Frame: 12 months ]N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786108
|Contact: Zhibin Baifirstname.lastname@example.org|
|Zhongda Hospital,Southeast University||Recruiting|
|Nanjing, Jiangsu, China, 210009|
|Contact: Zhibin Bai email@example.com|
|Principal Investigator:||Gao-jun Teng, Ph.D,MD||Zhongda Hospital Southeast University|