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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention/Bariatric Embolization | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Embolization Device | Device | Embosphere Microspheres |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Unit of Measure: mmHg | 12 Months |
| Lipid Panel | Unit of Measure: mg/dL, Total cholesterol, High-density lipoprotein cholesterol (HDL-C) - often called "good cholesterol" , Low-density lipoprotein cholesterol (LDL-C) - often called "bad cholesterol" and Triglycerides |
Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention/Bariatric Embolization | Artificial Embolization Device: Embosphere Microspheres |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention/Bariatric Embolization | Artificial Embolization Device: Embosphere Microspheres |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%). | Posted | Mean | Standard Deviation | percentage of excess weight loss | 12 Months |
|
|
30 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention/Bariatric Embolization | Artificial Embolization Device: Embosphere Microspheres |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asymptomatic gastric ulcers discovered on endoscopy | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Clifford Weiss | Johns Hopkins Univesity | 4106141046 | cweiss@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2015 | Sep 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 12 Months |
| Ghrelin Levels | Unit of Measure: pg/mL, Ghrelin on the other hand is a fast-acting hormone, seemingly playing a role in meal initiation. | 12 Months |
| Serum Obesity Hormone(Leptin) | This will be assessed by Leptin concentration Unit of Measure: pg/mL, Leptin is a mediator of long-term regulation of energy balance, suppressing food intake and thereby inducing weight loss. | 12 Months |
| Eating and Hunger/Satiety Assessments | Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores | 12 Months |
| Quality of Life Parameters Survey | Unit of Measure: N/A Utilizing Short Form Health Survey (SF)-36 and Impact of Weight on Quality of Life (IWQOL)-Lite | 12 Months |
| Food Intake | Documented via journal entries | 12 Months |
| Results From Endoscopy | Photos and clinical reports analyzed | 12 Months |
| Gastric Motility/Emptying | Unit of Measure: (t 1/2) in minutes, A gastric emptying scan (GES) is a nuclear medicine exam that uses a radioactive material that you will eat in a meal. You will eat this meal in the Radiology department before your scan. The radioactive material allows doctors to see how your stomach empties. This scan is used to help diagnose conditions called motility disorders. These are conditions that change the way the stomach contracts and moves food into your intestines. A GES is a form of radiology, because radiation is used to take pictures of your body. | 12 Months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Other Pre-specified | Blood Pressure | Unit of Measure: mmHg | Not Posted | 12 Months | Participants |
| Other Pre-specified | Lipid Panel | Unit of Measure: mg/dL, Total cholesterol, High-density lipoprotein cholesterol (HDL-C) - often called "good cholesterol" , Low-density lipoprotein cholesterol (LDL-C) - often called "bad cholesterol" and Triglycerides | Not Posted | 12 Months | Participants |
| Other Pre-specified | Ghrelin Levels | Unit of Measure: pg/mL, Ghrelin on the other hand is a fast-acting hormone, seemingly playing a role in meal initiation. | Not Posted | 12 Months | Participants |
| Other Pre-specified | Serum Obesity Hormone(Leptin) | This will be assessed by Leptin concentration Unit of Measure: pg/mL, Leptin is a mediator of long-term regulation of energy balance, suppressing food intake and thereby inducing weight loss. | Not Posted | 12 Months | Participants |
| Other Pre-specified | Eating and Hunger/Satiety Assessments | Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores | Not Posted | 12 Months | Participants |
| Other Pre-specified | Quality of Life Parameters Survey | Unit of Measure: N/A Utilizing Short Form Health Survey (SF)-36 and Impact of Weight on Quality of Life (IWQOL)-Lite | Not Posted | 12 Months | Participants |
| Other Pre-specified | Food Intake | Documented via journal entries | Not Posted | 12 Months | Participants |
| Other Pre-specified | Results From Endoscopy | Photos and clinical reports analyzed | Not Posted | 12 Months | Participants |
| Other Pre-specified | Gastric Motility/Emptying | Unit of Measure: (t 1/2) in minutes, A gastric emptying scan (GES) is a nuclear medicine exam that uses a radioactive material that you will eat in a meal. You will eat this meal in the Radiology department before your scan. The radioactive material allows doctors to see how your stomach empties. This scan is used to help diagnose conditions called motility disorders. These are conditions that change the way the stomach contracts and moves food into your intestines. A GES is a form of radiology, because radiation is used to take pictures of your body. | Not Posted | 12 Months | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 8 |
| 20 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |