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Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity
This study has been completed.
Study NCT00166205   Information provided by Ethicon Endo-Surgery
First Received: September 9, 2005   Last Updated: January 23, 2009   History of Changes
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition: Obesity, Morbid
Intervention: Device: Swedish Adjustable Gastric Band

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at twelve U.S. sites representative of the intended use of the SAGB in terms of both the subject population and the medical community. Subjects were recruited from a wide, heterogeneous subject population. Dates of recruitment June, 2003 to November, 2003.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
405 Subjects were consented. 129 did not meet screening criteria. 276 subjects were enrolled and received the SAGB device.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Participant Flow:   Overall Study
  Swedish Adjustable Gastric Band (SAGB)
STARTED   276  
      Intervention - SAGB Surgery               276  
COMPLETED   228  
NOT COMPLETED   48  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Baseline Measures
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants  
[units: participants]
 		276
Age  
[units: participants]
 		 
<=18 years 0
Between 18 and 65 years 276
>=65 years 0
Age  
[units: years]
Mean ± Standard Deviation 		38.6 ± 9.4
Gender  
[units: participants]
 		 
Female 216
Male 60
Region of Enrollment  
[units: participants]
 		 
United States 276
Mean Excess Body Weight[1]
[units: Pounds]
Mean ± Standard Deviation 		130.0 ± 33.1
[1] Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)   [ 3 years ]

Measure Type Primary
Measure Title Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)
Measure Description Percent of device-related adverse events (AEs) and device malfunctions occurring in subjects implanted with the Swedish Adjustable Gastric Band from baseline throughout the three-year post-operative period.
Time Frame 3 years  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT)

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)
[units: Percent of Subjects]
 		69.6


Statistical Analysis 1 for Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Percent of ITT subjects [2] 69.6
95% Confidence Interval ( 63.8 to 74.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  A sample size of 215, the adverse event (AE) rate at three years could be estimated with precision as determined by the interval half-width of approximately ± 7%.
[2] Other relevant estimation information:
  No text entered.



2.  Primary:   Percent Excess Weight Loss   [ 3 Years Post Operative ]

Measure Type Primary
Measure Title Percent Excess Weight Loss
Measure Description Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.
Time Frame 3 Years Post Operative  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT), Last Observation Carried Forward (LOCF)

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Percent Excess Weight Loss
[units: Percent Excess Weight Loss]
Mean ( 95% Confidence Interval ) 		41.1
( 38.1 to 44.1 )


Statistical Analysis 1 for Percent Excess Weight Loss
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Method [2] t-test, 1 sided
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  A one-sided paired t-test would have 80% power to reject the null hypothesis in favor of the alternative (i.e., that the SAGB system is not inferior to the clinically meaningful result of 36.2 for 224 subjects) assuming: a standard deviation (SD) of (21.6), an equivalent limit difference of (3.6), and a significance level of 0.05.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Changes in Excess Body Weight (EBW)   [ 3 years ]

Measure Type Secondary
Measure Title Changes in Excess Body Weight (EBW)
Measure Description Changes in excess body weight at 3-years post-operative minus baseline excess weight. Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range.
Time Frame 3 years  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Changes in Excess Body Weight (EBW)
[units: Pounds]
Mean ± Standard Deviation 		75.7 ± 39.8


Statistical Analysis 1 for Changes in Excess Body Weight (EBW)
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Mean [2] 75.7
Standard Deviation ± 39.8
95% Confidence Interval ( 70.5 to 80.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



4.  Secondary:   Changes in Body Mass Index (BMI)   [ 3 years ]

Measure Type Secondary
Measure Title Changes in Body Mass Index (BMI)
Measure Description Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.
Time Frame 3 years  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Changes in Body Mass Index (BMI)
[units: kg/m2]
Mean ± Standard Deviation 		35.7 ± 6.2


Statistical Analysis 1 for Changes in Body Mass Index (BMI)
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Mean [2] 35.7
Standard Deviation ± 6.2
95% Confidence Interval ( 34.9 to 36.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



5.  Secondary:   Change in Absolute Weight   [ 3 years ]

Measure Type Secondary
Measure Title Change in Absolute Weight
Measure Description Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.
Time Frame 3 years  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Change in Absolute Weight
[units: Pounds]
Mean ± Standard Deviation 		51.3 ± 30.8


Statistical Analysis 1 for Change in Absolute Weight
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Mean [2] 51.3
Standard Deviation ± 45.8
95% Confidence Interval ( 47.6 to 54.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



6.  Secondary:   Changes in Quality of Life (QOL) Measures   [ 3 years ]

Measure Type Secondary
Measure Title Changes in Quality of Life (QOL) Measures
Measure Description Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.
Time Frame 3 years  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Changes in Quality of Life (QOL) Measures
[units: Units on a scale]
Mean ± Standard Deviation 		10.4 ± 10.3


Statistical Analysis 1 for Changes in Quality of Life (QOL) Measures
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Mean Difference (Net) [2] 10.4
Standard Deviation ± 10.3
95% Confidence Interval ( 9.2 to 11.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Value at 36 months minus value at baseline. Positive values indicate improved Quality of Life (QOL)



7.  Secondary:   Changes in Glycosylated Hemoglobin (HbA1c)   [ 3 years ]

Measure Type Secondary
Measure Title Changes in Glycosylated Hemoglobin (HbA1c)
Measure Description Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.
Time Frame 3 years  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Changes in Glycosylated Hemoglobin (HbA1c)
[units: Percent of total hemogloobin]
Mean ± Standard Deviation 		5.7 ± 0.7


Statistical Analysis 1 for Changes in Glycosylated Hemoglobin (HbA1c)
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Mean [2] 5.7
Standard Deviation ± 0.7
95% Confidence Interval ( 5.6 to 5.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



8.  Secondary:   Number of All Adverse Events of Subjects Implanted With the SAGB   [ 3 Years ]

Measure Type Secondary
Measure Title Number of All Adverse Events of Subjects Implanted With the SAGB
Measure Description The evaluation of all Adverse Events of subjects implanted with the Swedish Adjustable Gastric Band throughout the three-year post-operative period (related to device and unrelated to device).
Time Frame 3 Years  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Number of All Adverse Events of Subjects Implanted With the SAGB
[units: Total Number of Adverse Events]
 		2400

No statistical analysis provided for Number of All Adverse Events of Subjects Implanted With the SAGB



9.  Secondary:   Changes in High Density Lipoproteins (HDL)   [ 3 year ]

Measure Type Secondary
Measure Title Changes in High Density Lipoproteins (HDL)
Measure Description Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.
Time Frame 3 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Changes in High Density Lipoproteins (HDL)
[units: Mg/dl]
Mean ± Standard Deviation 		56.4 ± 14.7


Statistical Analysis 1 for Changes in High Density Lipoproteins (HDL)
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Mean [2] 56.4
Standard Deviation ± 14.7
95% Confidence Interval ( 54.5 to 58.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



10.  Secondary:   Changes in Low Density Lipoproteins (LDL)   [ 3 years ]

Measure Type Secondary
Measure Title Changes in Low Density Lipoproteins (LDL)
Measure Description Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.
Time Frame 3 years  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Changes in Low Density Lipoproteins (LDL)
[units: Mg/dl]
Mean ± Standard Deviation 		114.5 ± 32.3


Statistical Analysis 1 for Changes in Low Density Lipoproteins (LDL)
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Mean [2] 114.5
Standard Deviation ± 32.3
95% Confidence Interval ( 110.1 to 118.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



11.  Secondary:   Changes in Total Cholesterol   [ 3 years ]

Measure Type Secondary
Measure Title Changes in Total Cholesterol
Measure Description Changes in Total Cholesterol, at three-years post-operative minus baseline.
Time Frame 3 years  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Swedish Adjustable Gastric Band (SAGB) No text entered.

Measured Values
  Swedish Adjustable Gastric Band (SAGB)
Number of Participants Analyzed
[units: participants] 		276
Changes in Total Cholesterol
[units: Mg/dl]
Mean ± Standard Deviation 		193.5 ± 36.9


Statistical Analysis 1 for Changes in Total Cholesterol
Groups [1] Swedish Adjustable Gastric Band (SAGB)
Mean [2] 193.5
Standard Deviation ± 36.9
95% Confidence Interval ( 188.6 to 198.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Sheryl Helsinger, Director
Organization: Worldwide Clinical Operations
phone: 513-337-3079
e-mail: shelsing@its.jnj.com


No publications provided


Responsible Party: Clinical Operations ( Sheryl Helsinger, Director )
Study ID Numbers: CI-02-0006
Study First Received: September 9, 2005
Results First Received: October 21, 2008
Last Updated: January 23, 2009
ClinicalTrials.gov Identifier: NCT00166205     History of Changes
Health Authority: United States: Food and Drug Administration





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