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Trial record 3 of 614 for:    "Obesity, Morbid"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00166205
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : December 11, 2008
Last Update Posted : September 1, 2015
Sponsor:
Information provided by:
Ethicon Endo-Surgery

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity, Morbid
Intervention Device: Swedish Adjustable Gastric Band
Enrollment 276
Recruitment Details 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 405 Subjects were consented. 129 did not meet screening criteria. 276 subjects were enrolled and received the SAGB device.
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 276
Intervention - SAGB Surgery 276
Completed 228
Not Completed 48
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 276
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 276 participants
<=18 years
0
   0.0%
Between 18 and 65 years
276
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 276 participants
38.6  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 276 participants
Female
216
  78.3%
Male
60
  21.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 276 participants
276
Mean Excess Body Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 276 participants
130.0  (33.1)
[1]
Measure Description: 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.
1.Primary Outcome
Title Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)
Hide 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
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Intent to Treat (ITT)
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
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[Not Specified]
Overall Number of Participants Analyzed 276
Measure Type: Number
Unit of Measure: Percent of Subjects
69.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments 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%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent of ITT subjects
Estimated Value 69.6
Confidence Interval 95%
63.8 to 74.9
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percent Excess Weight Loss
Hide Description Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.
Time Frame 3 Years Post Operative
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Intent to Treat (ITT), Last Observation Carried Forward (LOCF)
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
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[Not Specified]
Overall Number of Participants Analyzed 276
Mean (95% Confidence Interval)
Unit of Measure: Percent Excess Weight Loss
41.1
(38.1 to 44.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Changes in Excess Body Weight (EBW)
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
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[Not Specified]
Overall Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: Pounds
75.7  (39.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 75.7
Confidence Interval 95%
70.5 to 80.8
Parameter Dispersion
Type: Standard Deviation
Value: 39.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Changes in Body Mass Index (BMI)
Hide Description Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.
Time Frame 3 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
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[Not Specified]
Overall Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: kg/m2
35.7  (6.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 35.7
Confidence Interval 95%
34.9 to 36.5
Parameter Dispersion
Type: Standard Deviation
Value: 6.2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Absolute Weight
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
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[Not Specified]
Overall Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: Pounds
51.3  (30.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 51.3
Confidence Interval 95%
47.6 to 54.9
Parameter Dispersion
Type: Standard Deviation
Value: 45.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Changes in Quality of Life (QOL) Measures
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
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[Not Specified]
Overall Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: Units on a scale
10.4  (10.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.4
Confidence Interval 95%
9.2 to 11.7
Parameter Dispersion
Type: Standard Deviation
Value: 10.3
Estimation Comments Value at 36 months minus value at baseline. Positive values indicate improved Quality of Life (QOL)
7.Secondary Outcome
Title Changes in Glycosylated Hemoglobin (HbA1c)
Hide Description Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
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[Not Specified]
Overall Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: Percent of total hemogloobin
5.7  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 5.7
Confidence Interval 95%
5.6 to 5.8
Parameter Dispersion
Type: Standard Deviation
Value: 0.7
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of All Adverse Events of Subjects Implanted With the SAGB
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 276
Measure Type: Number
Unit of Measure: Total Number of Adverse Events
2400
9.Secondary Outcome
Title Changes in High Density Lipoproteins (HDL)
Hide Description Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
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[Not Specified]
Overall Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: Mg/dl
56.4  (14.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 56.4
Confidence Interval 95%
54.5 to 58.4
Parameter Dispersion
Type: Standard Deviation
Value: 14.7
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Changes in Low Density Lipoproteins (LDL)
Hide Description Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: Mg/dl
114.5  (32.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 114.5
Confidence Interval 95%
110.1 to 118.8
Parameter Dispersion
Type: Standard Deviation
Value: 32.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Changes in Total Cholesterol
Hide Description Changes in Total Cholesterol, at three-years post-operative minus baseline.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: Mg/dl
193.5  (36.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Swedish Adjustable Gastric Band (SAGB)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 193.5
Confidence Interval 95%
188.6 to 198.4
Parameter Dispersion
Type: Standard Deviation
Value: 36.9
Estimation Comments [Not Specified]
Time Frame Date of surgery to 3 years post-surgery
Adverse Event Reporting Description Subjects were questioned at all visits regarding any changes in their physical health.
 
Arm/Group Title Swedish Adjustable Gastric Band (SAGB)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Swedish Adjustable Gastric Band (SAGB)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Swedish Adjustable Gastric Band (SAGB)
Affected / at Risk (%) # Events
Total   78/276 (28.26%)    
Blood and lymphatic system disorders   
Lymphadenopathy  1  1/276 (0.36%)  1
Cardiac disorders   
Atrial fibrillation  1  1/276 (0.36%)  1
Bradycardia  1  1/276 (0.36%)  1
Cardiomegaly  1  1/276 (0.36%)  1
Gastrointestinal disorders   
Abdominal hernia  1  1/276 (0.36%)  1
Abdominal pain  1  1/276 (0.36%)  1
Constipation  1  1/276 (0.36%)  1
Gastric dilatation  1  3/276 (1.09%)  3
Gastric outlet obstruction  1  3/276 (1.09%)  3
Gastric ulcer  1  1/276 (0.36%)  1
Gastritis  1  2/276 (0.72%)  2
Gastrointestinal oedema  1  1/276 (0.36%)  1
Gastrooesophageal reflux disease  1  1/276 (0.36%)  1
Haemorrhoids  1  1/276 (0.36%)  1
Oesophageal spasm  1  1/276 (0.36%)  1
Oesophagitis  1  1/276 (0.36%)  1
Pancreatitis due to biliary obstruction  1  1/276 (0.36%)  1
Peptic ulcer  1  1/276 (0.36%)  1
Umbilical hernia  1  1/276 (0.36%)  1
Vomiting  1  2/276 (0.72%)  3
General disorders   
Catheter related complication  1  14/276 (5.07%)  15
Chest pain  1  3/276 (1.09%)  3
Drug withdrawal syndromwe  1  1/276 (0.36%)  1
Impaired healing  1  1/276 (0.36%)  1
Migration of implant  1  15/276 (5.43%)  17
Hepatobiliary disorders   
Biliary colic  1  1/276 (0.36%)  1
Cholecystitis  1  4/276 (1.45%)  4
Cholecystitis acute  1  1/276 (0.36%)  1
Cholelithiasis  1  5/276 (1.81%)  5
Immune system disorders   
Hypersensitivity  1  1/276 (0.36%)  1
Infections and infestations   
Gastroenteritis  1  1/276 (0.36%)  1
Injection site infection  1  1/276 (0.36%)  1
Osteomyelitis  1  2/276 (0.72%)  2
Pneumonia  1  1/276 (0.36%)  1
Injury, poisoning and procedural complications   
Ankle fracture  1  1/276 (0.36%)  1
Device failure  1  1/276 (0.36%)  1
Foot fracture  1  1/276 (0.36%)  1
Gastrointestinal injury  1  2/276 (0.72%)  2
Injury  1  1/276 (0.36%)  1
Ligament injury  1  1/276 (0.36%)  1
Meniscus lesion  1  1/276 (0.36%)  1
Surgical procedure repeated  1  1/276 (0.36%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/276 (0.36%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc disorder  1  1/276 (0.36%)  1
Plantar fasciitis  1  1/276 (0.36%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myeloid leukemia  1  1/276 (0.36%)  1
Breast cancer  1  1/276 (0.36%)  1
Nervous system disorders   
Benign intracranial hypertension  1  1/276 (0.36%)  1
Encephalopathy  1  1/276 (0.36%)  1
Intracranial pressure increased  1  1/276 (0.36%)  1
Lumbar spinal stenosis  1  1/276 (0.36%)  1
Syncope vasovagal  1  1/276 (0.36%)  1
Pregnancy, puerperium and perinatal conditions   
Premature separation of placenta  1  1/276 (0.36%)  1
Vomiting in pregnancy  1  1/276 (0.36%)  1
Psychiatric disorders   
Anxiety  1  1/276 (0.36%)  2
Renal and urinary disorders   
Renal tubular necrosis  1  1/276 (0.36%)  1
Urethral disorder  1  1/276 (0.36%)  1
Urinary retention  1  1/276 (0.36%)  1
Reproductive system and breast disorders   
Fibrocystic breast disease  1  1/276 (0.36%)  1
Vaginal haemorrhage  1  1/276 (0.36%)  1
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  1/276 (0.36%)  1
Pulmonary embolism  1  1/276 (0.36%)  1
Pulmonary microemboli  1  1/276 (0.36%)  1
Vascular disorders   
Deep vein thrombosis  1  3/276 (1.09%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Swedish Adjustable Gastric Band (SAGB)
Affected / at Risk (%) # Events
Total   266/276 (96.38%)    
Gastrointestinal disorders   
Vomiting  1  123/276 (44.57%) 
Nausea  1  89/276 (32.25%) 
Constipation  1  67/276 (24.28%) 
Gastrooesophageal reflux disease  1  52/276 (18.84%) 
Abdominal pain  1  28/276 (10.14%) 
Flatulence  1  28/276 (10.14%) 
Abdominal pain upper  1  27/276 (9.78%) 
Diarrhoea  1  26/276 (9.42%) 
Dysphagia  1  26/276 (9.42%) 
Dyspepsia  1  23/276 (8.33%) 
General disorders   
Fatigue  1  29/276 (10.51%) 
Injection site pain  1  18/276 (6.52%) 
Infections and infestations   
Nasopharynigitis  1  30/276 (10.87%) 
Influenza  1  26/276 (9.42%) 
Sinusitis  1  22/276 (7.97%) 
Urinary tract infection  1  21/276 (7.61%) 
Upper respiratory tract infection  1  20/276 (7.25%) 
Injury, poisoning and procedural complications   
Post procedural pain  1  66/276 (23.91%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  40/276 (14.49%) 
Arthralgia  1  27/276 (9.78%) 
Nervous system disorders   
Headache  1  37/276 (13.41%) 
Psychiatric disorders   
Depression  1  28/276 (10.14%) 
Insomnia  1  17/276 (6.16%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  24/276 (8.70%) 
Vascular disorders   
Hypertension  1  16/276 (5.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
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 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sheryl Helsinger, Director
Organization: Worldwide Clinical Operations
Phone: 513-337-3079
EMail: shelsing@its.jnj.com
Layout table for additonal information
Responsible Party: Sheryl Helsinger, Director, Clinical Operations
ClinicalTrials.gov Identifier: NCT00166205     History of Changes
Other Study ID Numbers: CI-02-0006
First Submitted: September 9, 2005
First Posted: September 14, 2005
Results First Submitted: October 21, 2008
Results First Posted: December 11, 2008
Last Update Posted: September 1, 2015