Morbid Obesity
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ethicon Endo-Surgery
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Received an implant with the Realize Band-C according to the following indications for use: 1. Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions. 2. Male and female adult patients (adult is defined as 18 years of age or older) 3. Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs. 2. Able to comprehend, follow, and give signed informed consent.
Exclusion criteria
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. Localized or systemic infection; 9. On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery; 10. Unable or unwilling to comply with dietary restrictions required by this procedure; 11. Known allergy to materials contained in the gastric band or its Injection Port; 12. Women who are pregnant; 13. Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Excess Weight Change From Baseline to 24 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Excess Weight Change From Baseline to 12 Months | 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. |
| Change in Body Mass Index From Baseline to 24 Months | 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. |
Countries
United States
Participant flow
Recruitment details
Subject recruitment began in November, 2009 at 7 surgical centers in the United States.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Realize Adjustable Gastric Band-C All subjects implanted with the Realize Gastric Band-C. | 231 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 59 |
| Overall Study | Not meeting eligibility criteria | 9 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Realize Adjustable Gastric Band-C |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 214 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 12.05 |
| Region of Enrollment United States | 231 participants |
| Sex: Female, Male Female | 180 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 200 / 231 |
| serious Total, serious adverse events | 9 / 231 |
Outcome results
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.
Time frame: Baseline to 24 months
Population: Intent to Treat Population - All subjects implanted with gastric band and signing informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Realize Adjustable Gastric Band-C | Percent Excess Weight Change From Baseline to 24 Months | 39.8 percent of excess weight at baseline | Standard Deviation 25.12 |
p-value: <0.000195% CI: [36.6, 43.1]t-test, 2 sided
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.
Time frame: Baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Realize Adjustable Gastric Band-C | Change in Body Mass Index From Baseline to 24 Months | -7.97 kilograms per meters squared | Standard Deviation 5.233 |
p-value: <0.000195% CI: [-8.65, -7.29]t-test, 2 sided
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.
Time frame: Baseline to 12 months
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Realize Adjustable Gastric Band-C | % Excess Weight Change From Baseline to 12 Months | 36.6 percent of excess weight at baseline | Standard Deviation 19.79 |
p-value: <0.000195% CI: [34, 39.2]t-test, 2 sided