Bariatric Arterial Embolization for Morbid Obesity
BAEMO
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJune 7, 2016
June 1, 2016
1.4 years
May 25, 2016
June 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Blood pressure
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Lipid Profile
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Number of Patients with Adverse Events
post-op 30 days
Ghrelin levels
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Abdominal fat content
Baseline, post-op 1 month,6 months,12 months
- +3 more secondary outcomes
Study Arms (2)
left gastric artery embolization
EXPERIMENTALPatients undergoing left gastric artery embolization
healthy diet and exercise
ACTIVE COMPARATORPatients undergoing healthy diet and exercise
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) \>30.
- No history of gastrointestinal surgery.
- Willing, able and mentally competent to provide written informed consent.
- Suitable for protocol therapy as determined by the interventional radiology Investigator.
- 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
- Aged between18 and 65 years old.
- More than one year's follow-up can be obtained reliably
You may not qualify if:
- Prior history of gastric pancreatic, hepatic, and/or splenic surgery
- Prior embolization to the stomach, spleen or liver
- Prior or current history of peptic ulcer disease
- Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
- Portal venous hypertension or cirrhosis
- Less than 18 years or older than 65 years of age
- 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
- Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
- Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
- 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.
- Patients currently taking or requiring chronic use of NSAID or steroid medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongda Hospitallead
Study Sites (1)
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, 210009, China
Related Publications (1)
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.
PMID: 29063494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gao-jun Teng, Ph.D,MD
Zhongda Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Radiology & Chair,Department of Radiology
Study Record Dates
First Submitted
May 25, 2016
First Posted
May 30, 2016
Study Start
May 1, 2016
Primary Completion
October 1, 2017
Study Completion
May 1, 2018
Last Updated
June 7, 2016
Record last verified: 2016-06