An interventional study of Artificial Embolization Device in Morbid Obesity, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-11-05.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 20 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Device: Artificial Embolization Device
Embosphere Microspheres
Also known as: Device Product Codes: 85 NAJ, Classification Name: Artificial Embolization Device, Regulation Numbers: 21 CFR 882.5950
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%).
Time frame: 12 Months
Blood Pressure
Unit of Measure: mmHg
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 12 Months
Eating and Hunger/Satiety Assessments
Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores
Time frame: 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
Time frame: 12 Months
Food Intake
Documented via journal entries
Time frame: 12 Months
Results From Endoscopy
Photos and clinical reports analyzed
Time frame: 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.
Time frame: 12 Months
| Milestone | Intervention/Bariatric Embolization |
|---|---|
| Started | 20 |
| Completed | 15 |
| Not completed | 5 |
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%).
| percentage of excess weight loss | Intervention/Bariatric Embolization |
|---|---|
| Percent Weight Change | 11.5 ± 10.2 |
Unit of Measure: mmHg
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Unit of Measure: pg/mL, Ghrelin on the other hand is a fast-acting hormone, seemingly playing a role in meal initiation.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores
Results for this outcome have not been posted.
Unit of Measure: N/A Utilizing Short Form Health Survey (SF)-36 and Impact of Weight on Quality of Life (IWQOL)-Lite
Results for this outcome have not been posted.
Documented via journal entries
Results for this outcome have not been posted.
Photos and clinical reports analyzed
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 30 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention/Bariatric Embolization | 0/20 (0%) | 0/20 (0%) | 8/20 (40%) |
| Event | Intervention/Bariatric Embolization |
|---|---|
| asymptomatic gastric ulcers discovered on endoscopyGastrointestinal disorders | 8/20 |
| Age, Categorical(Participants) | Intervention/Bariatric Embolization |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 1 |
| Age, Continuous(years) | Intervention/Bariatric Embolization |
|---|---|
| Mean | 44.5 ± 10.7 |
| Sex: Female, Male(Participants) | Intervention/Bariatric Embolization |
|---|---|
| Female | 16 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Intervention/Bariatric Embolization |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 12 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Intervention/Bariatric Embolization |
|---|---|
| United States | 20 |
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