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The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Excess Weight Change From Baseline to 24 Months | Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. | Baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| % Excess Weight Change From Baseline to 12 Months | Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. |
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Inclusion Criteria:
Received an implant with the Realize Band-C according to the following indications for use:
Able to comprehend, follow, and give signed informed consent.
Exclusion Criteria:
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At each participating center (after the initial 10 cases), all consecutively implanted patients, will be considered for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23642493 | Result | Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Schwiers M, Gutierrez M. Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):885-93. doi: 10.1016/j.soard.2013.02.009. Epub 2013 Mar 14. | |
| 21775219 | Result |
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This was a longitudinal, single arm, observational, non-comparative study of clinical outcomes. Subjects were asked to consent to data collection to the study parameters from their study records.
Subject recruitment began in November, 2009 at 7 surgical centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Realize Adjustable Gastric Band-C | All subjects implanted with the Realize Gastric Band-C. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat population defined as all subjects implanted with the Realize Gastric Band-C who signed informed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Realize Adjustable Gastric Band-C | All subjects implanted with the Realize Gastric Band-C. |
| 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 Excess Weight Change From Baseline to 24 Months | Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. | Intent to Treat Population - All subjects implanted with gastric band and signing informed consent. | Posted | Mean | Standard Deviation | percent of excess weight at baseline | Baseline to 24 months |
|
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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 | Realize Adjustable Gastric Band-C | All subjects implanted with the Realize Gastric Band-C. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers, Principal Biostatistician | Ethicon Endo-Surgery, Inc. | 513-337-1172 | mschwier@its.jnj.com |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Baseline to 12 months |
| Change in Body Mass Index From Baseline to 24 Months | Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline. | Baseline to 24 months |
| Celebration |
| Florida |
| United States |
| Joliet | Illinois | United States |
| Holland | Michigan | United States |
| Patchogue | New York | United States |
| Charlotte | North Carolina | United States |
| Houston | Texas | United States |
| Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Rodriguez CE, Gutierrez M. Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. population. Surg Obes Relat Dis. 2012 May-Jun;8(3):288-95. doi: 10.1016/j.soard.2011.05.004. Epub 2011 May 20. |
| Not meeting eligibility criteria |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | % Excess Weight Change From Baseline to 12 Months | Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. | Intent to Treat Population | Posted | Mean | Standard Deviation | percent of excess weight at baseline | Baseline to 12 months |
|
|
|
|
| Secondary | Change in Body Mass Index From Baseline to 24 Months | Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline. | Posted | Mean | Standard Deviation | kilograms per meters squared | Baseline to 24 months |
|
|
|
|
| 9 |
| 231 |
| 200 |
| 231 |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA\ | Systematic Assessment |
|
| Device migration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural pulmonary embolism | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDAR | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDA | Systematic Assessment |
|
The PIs agreed that the first publication of results should be made in conjunction with the presentation of a joint, multicenter publication of the results with the PIs from all sites contributing data, analyses, and comments. If this publication was not submitted within 12 months after conclusion of the Study at all sites, or after Sponsor confirmed there would be no multicenter Study publication, whichever is first, the PIs could have published the results from their individual sites.
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |