Bariatric Embolization of Arteries for the Treatment of Obesity

NCT02165124 | Completed Results DMC

• 1 other identifier: NA_00093563
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Obesity; Morbid Obesity; Bariatric Surgery; Embolization; Minimally Invasive; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Percent Weight Change

  This will be assessed by Percentage of excess weight loss (EWL). Percentage of excess weight loss is calculated by measuring the participants excess weight at baseline and then calculating the percentage of excess weight that was lost 12 months after surgery (for example if a participant has 100 pounds of excess weight prior to surgery and loses 30 pounds, their excess weight loss would be 30%).

  12 Months

Other Outcomes (9)

• Blood Pressure

  12 Months

• Lipid Panel

  12 Months

• Ghrelin Levels

  12 Months

Study Arms (1)

Intervention/Bariatric Embolization

EXPERIMENTAL

Device: Artificial Embolization Device

Interventions

Artificial Embolization Device DEVICE

Embosphere Microspheres

Also known as: Device Product Codes: 85 NAJ, Classification Name: Artificial Embolization Device, Regulation Numbers: 21 CFR 882.5950

Intervention/Bariatric Embolization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing, able and mentally competent to provide written informed consent.
• Body mass index (BMI) between 40-60.
• Residence within 25 miles of the enrolling institution
• 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.
• 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 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
• Aged 18 years or older.

You may not qualify if:

• Prior history of gastric pancreatic, hepatic, and/or splenic surgery
• Prior radiation to the upper abdomen
• Prior embolization to the stomach, spleen or liver
• Portal venous hypertension
• Prior or current history of peptic ulcer disease
• Hiatal Hernia
• Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
• Active H. Pylori infection
• Weight greater than 400 pound
• Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of \< 60 milliliters per minute
• Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease.
• 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.
• Pregnancy
• Preexisting chronic abdominal pain
• Positive stool occult study

Sponsors & Collaborators

• Johns Hopkins University: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Dr. Clifford Weiss
• Organization: Johns Hopkins Univesity

cweiss@jhmi.edu

4106141046

Study Officials

• Clifford R Weiss, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Aravind Arepally, M.D.

  Piedmont Healthcare

  PRINCIPAL INVESTIGATOR

• Dara L Kraitchman, V.M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Lawrence Cheskin, M.D.

  Johns Hopkins University

  STUDY CHAIR

• Aaron Fischman, M.D

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

  PRINCIPAL INVESTIGATOR

• Ellen Weiss, B.S, M.A, M.S

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 17, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-11

Locations

US (1)