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View Clinical Trial (Medical Research Study)
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A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects - NCT00730327- (Clinical Trial 235300)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy235300.aspx
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| City: |
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Memphis |
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State:
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TN |
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| Conditions: |
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Obesity |
| Purpose: |
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Safety and effectiveness of the BIB® System in conjunction with a behavior modification
program compared to the behavior modification program alone for weight loss in obese
subjects.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Have a BMI ≥ 30 and ≤ 40;
- Be male or female, between 18 and 65 years of age, inclusive;
- Have a history of obesity (BMI ≥ 30 kg/m2) for at least 2 years and have failed more
conservative weight-reduction alternatives, such as supervised diet, exercise and
behavioral modification programs;
- Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised
diet;
- Have reasonable weight loss expectations (accept a goal of losing up to 15% of body
weight after 26 weeks);
- Be able to follow requirements outlined in the protocol, including complying with the
visit schedule and behavioral modification program, and willing to undergo
protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia,
upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility
testing, and/or clinical laboratory testing;
- Must be willing to take prescribed proton pump inhibitors (PPIs);
- Be able to provide written informed consent;
- Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and
avoid pregnancy during the study if female of child-bearing potential.
Exclusion Criteria:
- History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated
appendectomy), obstruction, adhesive peritonitis, and/or hiatal hernia (> 2 cm);
- A patulous pyloric channel;
- History or symptoms of esophageal or GI motility disorders (not just those with <40%)
as these patients are particularly susceptible to the development of esophagitis;
- A history of myocardial infarction in the previous 6 months: New York Heart Associate
(NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial
fibrillation);
- Anemia;
- History or symptoms of varices, bowel obstruction, congenital or acquired GI
anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal,
hepatic, and/or pulmonary disease;
- History or symptoms of inflammatory bowel disease, such as Crohn's disease;
- History or symptoms of uncontrolled or unstable thyroid disease;
- Subjects with a positive test for Helicobacter pylori at screening;
- History or symptoms in the past 24 months of significant irritable bowel disease,
peritonitis, active esophagitis, gastric or duodenal ulceration, GI hemorrhage, or GI
bleeding;
- Type I diabetes;
- Placement of previous intragastric balloon or similar device;
- Ongoing treatment with anticoagulants, steroids, aspirin, non-steroidal
anti-inflammatory drugs (NSAIDS), or other medications known to be gastric irritants
or to reduce GI motility, and unwillingness to discontinue the use of these
concomitant medications;
- Concomitant use of prescription, non-prescription, or over-the-counter weight loss
medications or supplements at any time during the study;
- Evidence of untreated psychiatric or eating disorders, such as major depression,
schizophrenia, substance abuse, binge eating disorder, or bulimia;
- Pregnancy, breast feeding, or intention of becoming pregnant during the study (if
female of childbearing potential; |
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| Study is available at: |
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Memphis, TN
United States
Primary Contact:
Allergan Medical
Email: devicetrials@allergan.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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