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The purpose of this study is to collect additional safety, performance and effectiveness data of the Easyband gastric band medical device in the treatment of morbid obesity in 4 European countries where the device is a CE marked approved product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Easyband | Subjects who had the Easyband device implanted laparoscopically. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Easyband® | Device | The Easyband adjustable gastric band device is implanted laparoscopically around the top of the stomach to create a small pouch. Adjustments to increase or decrease the stoma size are made non-invasively by telemetric connection between an internal and external antenna. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Ease of Implantation | Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is "very easy" and 5 is "impossible." | < 1day |
| Measure | Description | Time Frame |
|---|---|---|
| % Excess Weight Loss | Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight. | 12 months |
| Change in BMI |
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Inclusion Criteria:
Exclusion Criteria:
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Weight loss clinic and bariatric surgeon clinics within a hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels | Belgium | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Easyband |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Easyband |
| 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 | Feasibility and Ease of Implantation | Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is "very easy" and 5 is "impossible." | Intent-to-treat | Number | percentage of subjects | < 1day |
|
|
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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 | Easyband |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 8.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Allergan Medical | (805) 961-5000 | devicetrials@allergan.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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|
Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months |
| 12 months |
| Change in Weight | Change in weight (in kilograms) at baseline to 12 months | 12 months |
| Peschiera |
| Italy |
| Nieuwegein | Netherlands |
| Cheshire | United Kingdom |
| Withdrawal by Subject |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | % Excess Weight Loss | Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight. | Mean | 95% Confidence Interval | percentage of excess weight loss | 12 months |
|
|
|
| Secondary | Change in BMI | Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months | Mean | 95% Confidence Interval | kg/m2 | 12 months |
|
|
|
| Secondary | Change in Weight | Change in weight (in kilograms) at baseline to 12 months | Mean | 95% Confidence Interval | pounds | 12 months |
|
|
|
| 29 |
| 110 |
| 87 |
| 110 |
| Myocardial infarction | Cardiac disorders | MedDRA (8.0) |
|
| Gastric dilatation | Gastrointestinal disorders | MedDRA (8.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (8.0) |
|
| Asthenia | General disorders | MedDRA (8.0) |
|
| Device malfunction | General disorders | MedDRA (8.0) |
|
| Medical device complication | General disorders | MedDRA (8.0) |
|
| Device related infection | Infections and infestations | MedDRA (8.0) |
|
| Incision site infection | Infections and infestations | MedDRA (8.0) |
|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA (8.0) |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (8.0) |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (8.0) |
|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (8.0) |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA (8.0) |
|
| Depression | Psychiatric disorders | MedDRA (8.0) |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA (8.0) |
|
| Medical device removal | Surgical and medical procedures | MedDRA (8.0) |
|
| Dysphagia | Gastrointestinal disorders |
|
| Abdominal pain upper | Gastrointestinal disorders |
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| Constipation | Gastrointestinal disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Medical device complication | General disorders |
|
| Medical device pain | General disorders |
|
| Medical device removal | Surgical and medical procedures |
|
At least one month prior to any proposed submission for publication or presentation of trial data, the PI will provide the Sponsor the manuscript for review, comment, and approval. No confidential information may be disclosed without Sponsor's written approval. If it is a multi-center trial, the first publication of the results shall be made in conjunction with the results from other Investigators at other centers.
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |