Trial Outcomes & Findings for Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity (NCT NCT00166205)

Last Updated: 2015-09-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

276 participants

Primary outcome timeframe

3 years

Results posted on

2015-09-01

Participant Flow

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.

405 Subjects were consented. 129 did not meet screening criteria. 276 subjects were enrolled and received the SAGB device.

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	276 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	38.6 years STANDARD_DEVIATION 9.4 • n=93 Participants
Sex: Female, Male Female	216 Participants n=93 Participants
Sex: Female, Male Male	60 Participants n=93 Participants
Region of Enrollment United States	276 participants n=93 Participants
Mean Excess Body Weight	130.0 Pounds STANDARD_DEVIATION 33.1 • n=93 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)	69.6 Percent of Subjects

PRIMARY outcome

Timeframe: 3 Years Post Operative

Population: Intent to Treat (ITT), Last Observation Carried Forward (LOCF)

Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Percent Excess Weight Loss	41.1 Percent Excess Weight Loss Interval 38.1 to 44.1

SECONDARY outcome

Timeframe: 3 years

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.

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Changes in Excess Body Weight (EBW)	75.7 Pounds Standard Deviation 39.8

SECONDARY outcome

Timeframe: 3 years

Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Changes in Body Mass Index (BMI)	35.7 kg/m2 Standard Deviation 6.2

SECONDARY outcome

Timeframe: 3 years

Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Change in Absolute Weight	51.3 Pounds Standard Deviation 30.8

SECONDARY outcome

Timeframe: 3 years

Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Changes in Quality of Life (QOL) Measures	10.4 Units on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: 3 years

Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Changes in Glycosylated Hemoglobin (HbA1c)	5.7 Percent of total hemogloobin Standard Deviation 0.7

SECONDARY outcome

Timeframe: 3 Years

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).

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Number of All Adverse Events of Subjects Implanted With the SAGB	2400 Total Number of Adverse Events

SECONDARY outcome

Timeframe: 3 year

Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Changes in High Density Lipoproteins (HDL)	56.4 Mg/dl Standard Deviation 14.7

SECONDARY outcome

Timeframe: 3 years

Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Changes in Low Density Lipoproteins (LDL)	114.5 Mg/dl Standard Deviation 32.3

SECONDARY outcome

Timeframe: 3 years

Changes in Total Cholesterol, at three-years post-operative minus baseline.

Outcome measures

Outcome measures
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 Participants
Changes in Total Cholesterol	193.5 Mg/dl Standard Deviation 36.9

Adverse Events

Swedish Adjustable Gastric Band (SAGB)

Serious events: 78 serious events

Other events: 266 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 participants at risk
Blood and lymphatic system disorders Lymphadenopathy	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Cardiac disorders Atrial fibrillation	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Cardiac disorders Bradycardia	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Cardiac disorders Cardiomegaly	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Abdominal hernia	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Abdominal pain	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Constipation	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Gastric dilatation	1.1% 3/276 • Number of events 3 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Gastric outlet obstruction	1.1% 3/276 • Number of events 3 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Gastric ulcer	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Gastritis	0.72% 2/276 • Number of events 2 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Gastrointestinal oedema	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Haemorrhoids	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Oesophageal spasm	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Oesophagitis	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Pancreatitis due to biliary obstruction	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Peptic ulcer	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Umbilical hernia	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Vomiting	0.72% 2/276 • Number of events 3 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
General disorders Catheter related complication	5.1% 14/276 • Number of events 15 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
General disorders Chest pain	1.1% 3/276 • Number of events 3 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
General disorders Drug withdrawal syndromwe	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
General disorders Impaired healing	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
General disorders Migration of implant	5.4% 15/276 • Number of events 17 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Hepatobiliary disorders Biliary colic	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Hepatobiliary disorders Cholecystitis	1.4% 4/276 • Number of events 4 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Hepatobiliary disorders Cholecystitis acute	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Hepatobiliary disorders Cholelithiasis	1.8% 5/276 • Number of events 5 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Immune system disorders Hypersensitivity	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Infections and infestations Gastroenteritis	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Infections and infestations Injection site infection	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Infections and infestations Osteomyelitis	0.72% 2/276 • Number of events 2 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Infections and infestations Pneumonia	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Injury, poisoning and procedural complications Ankle fracture	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Injury, poisoning and procedural complications Device failure	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Injury, poisoning and procedural complications Foot fracture	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Injury, poisoning and procedural complications Gastrointestinal injury	0.72% 2/276 • Number of events 2 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Injury, poisoning and procedural complications Injury	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Injury, poisoning and procedural complications Ligament injury	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Injury, poisoning and procedural complications Meniscus lesion	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Injury, poisoning and procedural complications Surgical procedure repeated	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Metabolism and nutrition disorders Dehydration	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukemia	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Nervous system disorders Benign intracranial hypertension	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Nervous system disorders Encephalopathy	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Nervous system disorders Intracranial pressure increased	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Nervous system disorders Lumbar spinal stenosis	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Nervous system disorders Syncope vasovagal	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Pregnancy, puerperium and perinatal conditions Vomiting in pregnancy	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Psychiatric disorders Anxiety	0.36% 1/276 • Number of events 2 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Renal and urinary disorders Renal tubular necrosis	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Renal and urinary disorders Urethral disorder	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Renal and urinary disorders Urinary retention	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Reproductive system and breast disorders Fibrocystic breast disease	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Reproductive system and breast disorders Vaginal haemorrhage	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Respiratory, thoracic and mediastinal disorders Pulmonary microemboli	0.36% 1/276 • Number of events 1 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Vascular disorders Deep vein thrombosis	1.1% 3/276 • Number of events 3 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.

Other adverse events

Other adverse events
Measure	Swedish Adjustable Gastric Band (SAGB) n=276 participants at risk
Gastrointestinal disorders Vomiting	44.6% 123/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Nausea	32.2% 89/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Constipation	24.3% 67/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Gastrooesophageal reflux disease	18.8% 52/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Abdominal pain	10.1% 28/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Flatulence	10.1% 28/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Abdominal pain upper	9.8% 27/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Diarrhoea	9.4% 26/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Dysphagia	9.4% 26/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Gastrointestinal disorders Dyspepsia	8.3% 23/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
General disorders Fatigue	10.5% 29/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
General disorders Injection site pain	6.5% 18/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Infections and infestations Nasopharynigitis	10.9% 30/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Infections and infestations Influenza	9.4% 26/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Infections and infestations Sinusitis	8.0% 22/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Infections and infestations Urinary tract infection	7.6% 21/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Infections and infestations Upper respiratory tract infection	7.2% 20/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Injury, poisoning and procedural complications Post procedural pain	23.9% 66/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Musculoskeletal and connective tissue disorders Back pain	14.5% 40/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Musculoskeletal and connective tissue disorders Arthralgia	9.8% 27/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Nervous system disorders Headache	13.4% 37/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Psychiatric disorders Depression	10.1% 28/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Psychiatric disorders Insomnia	6.2% 17/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Skin and subcutaneous tissue disorders Alopecia	8.7% 24/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.
Vascular disorders Hypertension	5.8% 16/276 • Date of surgery to 3 years post-surgery Subjects were questioned at all visits regarding any changes in their physical health.

Additional Information

Sheryl Helsinger, Director

Worldwide Clinical Operations

Phone: 513-337-3079

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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