5 Year Post-Approval Study With the REALIZE (TM) Adjustable Gastric Band - NCT00813462-32086 (Clinical Trial 261746)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy261746.aspx
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| City: |
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St. Augustine |
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State:
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FL |
| Zip Code: |
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32086 |
| Conditions: |
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Morbid Obesity |
| Purpose: |
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To determine the re-operation rate (band revision, band replacement and explants resulting
from serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post
implant.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Subjects eligible to participate in this study must fulfill all of the following
criteria:
1. Able to comprehend, follow and give informed consent;
2. 18 to 60 years of age (inclusive);
3. Body Mass Index (BMI) of > 40 kg/m2 and £ 55 kg/m2, or BMI ³ 35 kg/m2 and < 40
kg/m2 with one or more co-morbid conditions.
4. Candidate for surgical weight loss intervention in accordance with the
Instructions For Use (i.e., meets acceptable health criteria for major surgery).
Exclusion Criteria:
1. Women who are currently pregnant.
2. Previous malabsorptive or restrictive procedures performed for the treatment of
morbid obesity.
3. Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit
(1a).
4. Presence of any of the following medical conditions;
1. Inflammatory diseases of the gastrointestinal tract, including severe
intractable esophagitis, gastric ulceration or duodenal ulceration, or specific
inflammation such as Crohn's disease;
2. Severe cardiopulmonary disease or other serious organic disease;
3. Upper gastrointestinal bleeding conditions such as esophageal or gastric varices
or intestinal telangiectases;
4. Portal hypertension;
5. Anomalies of the gastrointestinal tract such as atresia or stenosis;
6. Cirrhosis of the liver;
7. Chronic pancreatitis;
8. Patients on chronic, long-term steroid treatment or steroids within 15 days of
surgery;
9. Unable or unwilling to comply with dietary restrictions required by this
procedure;
10. Known allergy to materials contained within the band or its injection port
(silicone elastomer containing 10% BaSO4, polyetheretherketone (PEEK), and
cobalt chromium)
5. Presence of terminal illness with life expectancy of £ 5 years.
6. Inability to refrain from use of anticoagulants or aspirin within 15 days prior to
surgery.
7. Acute or chronic infection (localized or systemic).
8. Participation in another clinical trial within 8 weeks of the Screening Visit (1a)
and for the duration of this trial.
9. Any medical condition or finding for which the Investigator utilizes their medical
discretion to determine the subject should be excluded due to inability to understand
or follow study procedures. |
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| Study is available at: |
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Robert T. Marema, MD
St. Augustine, FL 32086
United States
Primary Contact:
Marema
Phone: 904-819-5861 |
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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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