Bariatric Embolization of Arteries for the Treatment of Obesity

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

Interventions

DEVICE

Artificial Embolization Device

Embosphere Microspheres

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Clifford R Weiss, M.D. · Johns Hopkins University

• Aravind Arepally, M.D. · Piedmont Healthcare

• Dara L Kraitchman, V.M.D., Ph.D. · Johns Hopkins University

• Lawrence Cheskin, M.D. · Johns Hopkins University

• Aaron Fischman, M.D · Icahn School of Medicine at Mount Sinai - [email protected] ; 212-241-7409

• Ellen Weiss, B.S, M.A, M.S · Icahn School of Medicine at Mount Sinai - [email protected] ; 212-241-2317

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2017-12-31

Completion

2018-03-31

Countries

• United States

Study Locations