Bariatric Embolization of Arteries for the Treatment of Obesity

NCT ID: NCT02165124

Last Updated: 2018-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-03-31

Brief Summary

The purpose of this study is evaluate the safety and effectiveness of bariatric embolization as a minimally-invasive image-guided procedure for morbid obesity. In this procedure, specific blood vessels to the stomach are blocked in order to suppress some of the body's signals for feeling hungry, leading to weight loss.

Morbid obesity is currently treated with diet and exercise, medications, and surgery. This study is designed to help treat obesity using a minimally invasive, non-surgical, angiographic (through the blood vessel) approach. This procedure is similar to a common procedure used to treat bleeding within the stomach. This version of the procedure has been named "bariatric embolization".

Although there are over 40 hormones that limit food intake, there is only one hormone, ghrelin that has been shown to stimulate (prompt) food intake. In obese patients, eating fails to suppress ghrelin levels, which is believed to prevent feeling full after a meal and to lead to overeating. Due to the strong hunger craving effects of ghrelin, this hormone has been a target for the treatment of obesity and weight loss. More recently, ghrelin has been shown to have a significant role in the long-term effect of weight loss in bariatric (obesity) surgery where ghrelin levels are shown to be much lower when compared to untreated patients.

Recent data collected in animals in has shown that blocking blood vessels to a particular portion of the stomach (bariatric embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and decrease short-term weight gain. In a study of 5 people, there was a decrease in ghrelin levels and weight loss in the first month after the procedure, but there is no information about the effects of the procedure over longer periods of time.

The investigator hopes to learn if bariatric embolization results in safe and effective weight loss in people who are morbidly obese.

Conditions

Morbid Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention/Bariatric Embolization

Group Type: EXPERIMENTAL

Artificial Embolization Device

Intervention Type: DEVICE

Embosphere Microspheres

Interventions

Artificial Embolization Device

Embosphere Microspheres

Intervention Type: DEVICE

Other Intervention Names

Device Product Codes: 85 NAJ; Classification Name: Artificial Embolization Device; Regulation Numbers: 21 CFR 882.5950

Eligibility Criteria

Inclusion Criteria

1. Willing, able and mentally competent to provide written informed consent.

2. Body mass index (BMI) between 40-60.

3. Residence within 25 miles of the enrolling institution

4. Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography.

5. Suitable for protocol therapy as determined by the interventional radiology Investigator.

6. Adequate hematological, hepatic and renal function as follows:

Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L International Normalized Ratio (INR) <1.5

Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L

Renal Estimated Glomerular Filtration Rate (GFR) > 60ml/min.1.73m2

7. Aged 18 years or older.

Exclusion Criteria

1. Prior history of gastric pancreatic, hepatic, and/or splenic surgery

2. Prior radiation to the upper abdomen

3. Prior embolization to the stomach, spleen or liver

4. Portal venous hypertension

5. Prior or current history of peptic ulcer disease

6. Hiatal Hernia

7. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.

8. Active H. Pylori infection

9. Weight greater than 400 pound

10. Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute

11. Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease.

12. Complicated arterial anatomic variants including left gastric artery arising from the aorta, and/or hepatic arterial supply via a replaced or accessory left hepatic artery arising from the left gastric artery.

13. Pregnancy

14. Preexisting chronic abdominal pain

15. Positive stool occult study

16. Abnormal Endoscopy

17. Abnormal Nuclear Gastric Motility examination

18. American Society of Anaesthesiologists (ASA) Class 4 or 5 (very high risk surgical candidates: class 4= incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study will be excluded from participation. This exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects.

19. History of Inflammatory Bowel Disease

20. Autoimmune disease

21. Cirrhosis

22. Known history of allergy to iodinated contrast media

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clifford R Weiss, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Aravind Arepally, M.D.

Role: PRINCIPAL_INVESTIGATOR

Piedmont Healthcare

Dara L Kraitchman, V.M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Lawrence Cheskin, M.D.

Role: STUDY_CHAIR

Johns Hopkins University

Aaron Fischman, M.D

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai - aaron.fischman@mountsinai.org ; 212-241-7409

Ellen Weiss, B.S, M.A, M.S

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai - ellen.weiss@mountsinai.org ; 212-241-2317

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NA_00093563

Identifier Type: -

Identifier Source: org_study_id