Bariatric Arterial Embolization for Morbid Obesity (BAEMO)

• ClinicalTrials.gov Identifier: NCT02786108
• Recruitment Status: Unknown
• First Posted: May 30, 2016
• Last Update Posted: June 7, 2016
• Sponsor: Zhongda Hospital
• Information provided by (Responsible Party): Gao-jun Teng, Zhongda Hospital

Tracking Information

• First Submitted Date: May 25, 2016
• First Posted Date: May 30, 2016
• Last Update Posted Date: June 7, 2016
• Study Start Date: May 2016
• Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2016)

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.

• Original Primary Outcome Measures (submitted: May 25, 2016): Weight Loss [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]

Current Secondary Outcome Measures (submitted: June 5, 2016)

• 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.

Original Secondary Outcome Measures (submitted: May 25, 2016)

• Blood pressure [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]
• Lipid Profile [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]
• Number of Patients with Adverse Events [ Time Frame: post-op 30 days ]
• Ghrelin levels [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]
• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bariatric Arterial Embolization for Morbid Obesity
• Official Title: Bariatric Arterial Embolization for Morbid Obesity

Brief 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Morbid Obesity

Intervention

• Procedure: left gastric artery embolization
• Behavioral: healthy diet and exercise

Study Arms

• Experimental: left gastric artery embolization
  Patients undergoing left gastric artery embolization
  Intervention: Procedure: left gastric artery embolization
• Active Comparator: healthy diet and exercise
  Patients undergoing healthy diet and exercise
  Intervention: Behavioral: healthy diet and exercise

• Publications *: Bai ZB, Qin YL, Deng G, Zhao GF, Zhong BY, Teng GJ. Bariatric Embolization of the Left Gastric Arteries for the Treatment of Obesity: 9-Month Data in 5 Patients. Obes Surg. 2018 Apr;28(4):907-915. doi: 10.1007/s11695-017-2979-9.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 25, 2016): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2018
• Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02786108
• Other Study ID Numbers: 2015ZDSYLL068.0
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gao-jun Teng, Zhongda Hospital
• Study Sponsor: Zhongda Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gao-jun Teng, Ph.D,MD; Zhongda Hospital Southeast University

• PRS Account: Zhongda Hospital
• Verification Date: June 2016