Morbid Obesity
Conditions
Keywords
Obesity, Morbid Obesity
Brief summary
The purpose of the study is to evaluate the long term safety of the Swedish Adjustable Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed 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.
Detailed description
NCT00543140 (CI-06-0001) is the 2 year Safety and QOL subject follow-up study to NCT00166205 (CI-02-0006), completed on November 10, 2008. As a condition of approval, the FDA required additional subjects with long-term safety data. These subjects enrolled under protocol CI-07-0006 (NCT00813462)-5 Year Post-Approval Study With the REALIZE (TM) Adjustable Gastric Band. Protocol CI-06-0001 was amended to combine these study subjects with study subjects from CI-07-0006. NCT00543140 (CI-06-0001) will not be completed (analysis of results) until the additional subjects in NCT00813462 (CI-07-0006) complete this study since the original intent was to pool the data together from the above two studies to obtain the appropriate sample size for estimation of the re-operation rate at 4 and 5 years post implantation.
Interventions
DEVICEREALIZE™ Swedish Adjustable Gastric Band
Laparoscopic placement of the Swedish Adjustable Gastric Band
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
CI-06-0001 Inclusion Criteria: Subjects eligible to participate in this study must fulfill all of the following criteria: 1. Able to comprehend, follow and give signed informed consent; 2. Consented to, and participated in EES Protocol CI-02-0006 titled A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity; 3. Currently have an SAGB implant in place; 4. Able to commit to long-term follow-up; up to 5 years after SAGB implantation, including band adjustment visits; and 5. Living within the contiguous U.S. CI-07-0006 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). CI-06-0001
Exclusion criteria
Subjects with the following are not eligible to participate in this clinical trial and must not be enrolled in this study: a. Consented to, and participated in EES Protocol CI-02-0006 titled A aSingle-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity; and have had the SAGB explanted. CI-07-0006
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant. | 5 years | A reoperation was identified by satisfying all of the following criteria: * Is an SAE or is the action taken as the result of an SAE; * Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device; * Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and * Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant. | 5 years | The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value. |
| Percent Change in Excess Body Weight at 5 Years Post-implant | 5 years | — |
| Change in SF-36 Health Survey Physical Component at 5 Years Post Implant | 5 years | Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life. |
| Change in SF-36 Health Survey Mental Component at 5 Years Post Implant | 5 years | Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| REALIZE™ Adjustable Gastric Band All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band | 303 |
| Total | 303 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Conversion to different procedure | 1 |
| Overall Study | Death | 1 |
| Overall Study | Insufficient weight loss | 10 |
| Overall Study | Lost to Follow-up | 33 |
| Overall Study | Protocol Violation | 10 |
| Overall Study | SAE leading to explant of SAGB | 3 |
| Overall Study | Subject moved | 1 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | REALIZE™ Adjustable Gastric Band |
|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 9.9 |
| Body Mass Index (kg/m^2) | 44.1 kilograms per meters squared STANDARD_DEVIATION 4.76 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 8 participants |
| Race/Ethnicity, Customized Black, not of Hispanic origin | 27 participants |
| Race/Ethnicity, Customized Caucasian, not of Hispanic origin | 205 participants |
| Race/Ethnicity, Customized Hispanic | 55 participants |
| Race/Ethnicity, Customized Other | 8 participants |
| Region of Enrollment United States | 303 participants |
| Sex: Female, Male Female | 242 Participants |
| Sex: Female, Male Male | 61 Participants |
| Weight (lbs) | 272.2 pounds STANDARD_DEVIATION 40.78 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 302 / 303 |
| serious Total, serious adverse events | 138 / 303 |
Outcome results
Primary
Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant.
A reoperation was identified by satisfying all of the following criteria: * Is an SAE or is the action taken as the result of an SAE; * Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device; * Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and * Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device.
Time frame: 5 years
Population: Consists of subjects who had a device implanted under protocol CI-07-0006 and subjects implanted under protocol CI-02-0006 and subsequently enrolled under protocol CI-06-0001.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REALIZE™ Adjustable Gastric Band | Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant. | 8.91 percentage of subjects |
Comparison: The primary analysis used a one-sided binomial exact test method by Clopper and Pearson to determine if the rate of reoperations observed in Years 4 and 5 (combined) of the study was significantly less than 8%. The null hypothesis was that the reoperation rate was greater than or equal to 8%.p-value: 0.6919Exact Binomial method
Secondary
Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.
The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value.
Time frame: 5 years
Population: All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| REALIZE™ Adjustable Gastric Band | Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant. | -0.22 percentage |
Secondary
Change in SF-36 Health Survey Mental Component at 5 Years Post Implant
Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.
Time frame: 5 years
Population: All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| REALIZE™ Adjustable Gastric Band | Change in SF-36 Health Survey Mental Component at 5 Years Post Implant | 1.1 Unitless scale ranging 0 to 100 |
Secondary
Change in SF-36 Health Survey Physical Component at 5 Years Post Implant
Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.
Time frame: 5 years
Population: All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| REALIZE™ Adjustable Gastric Band | Change in SF-36 Health Survey Physical Component at 5 Years Post Implant | 8.1 unitless scale ranging 0 to 100 |
Secondary
Percent Change in Excess Body Weight at 5 Years Post-implant
Time frame: 5 years
Population: All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| REALIZE™ Adjustable Gastric Band | Percent Change in Excess Body Weight at 5 Years Post-implant | -35.6 percentage of excess body weight |