Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition:	Obesity, Morbid
Intervention:	Device: Swedish Adjustable Gastric Band

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

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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

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1. Primary:

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

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2. Primary:

Percent Excess Weight Loss [ 3 Years Post Operative ]

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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 ]

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4. Secondary:

Changes in Body Mass Index (BMI) [ 3 years ]

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5. Secondary:

Change in Absolute Weight [ 3 years ]

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6. Secondary:

Changes in Quality of Life (QOL) Measures [ 3 years ]

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7. Secondary:

Changes in Glycosylated Hemoglobin (HbA1c) [ 3 years ]

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8. Secondary:

Number of All Adverse Events of Subjects Implanted With the SAGB [ 3 Years ]

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9. Secondary:

Changes in High Density Lipoproteins (HDL) [ 3 year ]

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10. Secondary:

Changes in Low Density Lipoproteins (LDL) [ 3 years ]

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11. Secondary:

Changes in Total Cholesterol [ 3 years ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The PI shall have the right to publish the results of research to include in any publication. The PI will provide the Sponsor with at least sixty (60) days for review of a manuscript. No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.

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