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

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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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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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