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Bariatric Arterial Embolization for Morbid Obesity (BAEMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Gao-jun Teng, Zhongda Hospital

Tracking Information
First Submitted Date  ICMJE May 25, 2016
First Posted Date  ICMJE May 30, 2016
Last Update Posted Date June 7, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: May 25, 2016)
Weight Loss [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Bariatric Arterial Embolization for Morbid Obesity
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE
  • Procedure: left gastric artery embolization
  • Behavioral: healthy diet and exercise
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 25, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02786108
Other Study ID Numbers  ICMJE 2015ZDSYLL068.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gao-jun Teng, Zhongda Hospital
Study Sponsor  ICMJE Zhongda Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gao-jun Teng, Ph.D,MD Zhongda Hospital Southeast University
PRS Account Zhongda Hospital
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP