Trial Outcomes & Findings for Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band (NCT NCT00543140)
NCT ID: NCT00543140
Last Updated: 2016-03-09
Results Overview
A reoperation was identified by satisfying all of the following criteria: * Is an SAE or is the action taken as the result of an SAE; * Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device; * Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and * Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
303 participants
Primary outcome timeframe
5 years
Results posted on
2016-03-09
Participant Flow
Participant milestones
| Measure |
REALIZE™ Adjustable Gastric Band
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Overall Study
STARTED
|
303
|
|
Overall Study
COMPLETED
|
231
|
|
Overall Study
NOT COMPLETED
|
72
|
Reasons for withdrawal
| Measure |
REALIZE™ Adjustable Gastric Band
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Overall Study
Lost to Follow-up
|
33
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Protocol Violation
|
10
|
|
Overall Study
Insufficient weight loss
|
10
|
|
Overall Study
SAE leading to explant of SAGB
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Subject moved
|
1
|
|
Overall Study
Conversion to different procedure
|
1
|
Baseline Characteristics
Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band
Baseline characteristics by cohort
| Measure |
REALIZE™ Adjustable Gastric Band
n=303 Participants
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 9.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian, not of Hispanic origin
|
205 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
55 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, not of Hispanic origin
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
303 participants
n=5 Participants
|
|
Weight (lbs)
|
272.2 pounds
STANDARD_DEVIATION 40.78 • n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
44.1 kilograms per meters squared
STANDARD_DEVIATION 4.76 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Consists of subjects who had a device implanted under protocol CI-07-0006 and subjects implanted under protocol CI-02-0006 and subsequently enrolled under protocol CI-06-0001.
A reoperation was identified by satisfying all of the following criteria: * Is an SAE or is the action taken as the result of an SAE; * Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device; * Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and * Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device.
Outcome measures
| Measure |
REALIZE™ Adjustable Gastric Band
n=303 Participants
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant.
|
8.91 percentage of subjects
Interval 5.95 to 12.7
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.
The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value.
Outcome measures
| Measure |
REALIZE™ Adjustable Gastric Band
n=227 Participants
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.
|
-0.22 percentage
Interval -0.33 to -0.11
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.
Outcome measures
| Measure |
REALIZE™ Adjustable Gastric Band
n=240 Participants
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Percent Change in Excess Body Weight at 5 Years Post-implant
|
-35.6 percentage of excess body weight
Interval -39.0 to -32.2
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.
Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.
Outcome measures
| Measure |
REALIZE™ Adjustable Gastric Band
n=233 Participants
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Change in SF-36 Health Survey Physical Component at 5 Years Post Implant
|
8.1 unitless scale ranging 0 to 100
Interval 6.6 to 9.5
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.
Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.
Outcome measures
| Measure |
REALIZE™ Adjustable Gastric Band
n=233 Participants
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Change in SF-36 Health Survey Mental Component at 5 Years Post Implant
|
1.1 Unitless scale ranging 0 to 100
Interval -0.4 to 2.6
|
Adverse Events
REALIZE™ Adjustable Gastric Band
Serious events: 138 serious events
Other events: 302 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
REALIZE™ Adjustable Gastric Band
n=303 participants at risk
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.99%
3/303 • Number of events 3 • Date of Surgery Through 5 Years Post Implantation
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Cardiac disorders
BRADYCARDIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Ear and labyrinth disorders
VERTIGO
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
GASTRIC DILATATION
|
2.3%
7/303 • Number of events 7 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
1.7%
5/303 • Number of events 5 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
VOMITING
|
1.7%
5/303 • Number of events 5 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.99%
3/303 • Number of events 3 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
0.99%
3/303 • Number of events 3 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
GASTRITIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
GASTROINTESTINAL OEDEMA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
NAUSEA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
OESOPHAGEAL DISORDER
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
OESOPHAGEAL OBSTRUCTION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
REGURGITATION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
VOLVULUS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
CATHETER RELATED COMPLICATION
|
5.0%
15/303 • Number of events 16 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
CHEST PAIN
|
1.3%
4/303 • Number of events 4 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
IMPLANT SITE PAIN
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
ASTHENIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
IMPLANT SITE HAEMATOMA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
PYREXIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
4.3%
13/303 • Number of events 13 • Date of Surgery Through 5 Years Post Implantation
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
2.6%
8/303 • Number of events 9 • Date of Surgery Through 5 Years Post Implantation
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.99%
3/303 • Number of events 3 • Date of Surgery Through 5 Years Post Implantation
|
|
Hepatobiliary disorders
BILIARY DYSKINESIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Hepatobiliary disorders
HEPATIC LESION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Immune system disorders
GRAFT VERSUS HOST DISEASE
|
0.33%
1/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.99%
3/303 • Number of events 3 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
OSTEOMYELITIS
|
0.99%
3/303 • Number of events 3 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
PNEUMONIA
|
0.99%
3/303 • Number of events 4 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
GASTROENTERITIS
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
IMPLANT SITE INFECTION
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
ABSCESS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
APPENDICEAL ABSCESS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
APPENDICITIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
BACTERIAL PYELONEPHRITIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
BRONCHITIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
KIDNEY INFECTION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
RENAL ABSCESS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
DEVICE MIGRATION
|
9.2%
28/303 • Number of events 31 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
DEVICE FAILURE
|
1.7%
5/303 • Number of events 5 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
DEVICE MALFUNCTION
|
0.99%
3/303 • Number of events 3 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
DEVICE OCCLUSION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
FAILURE OF IMPLANT
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
INJURY
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
LIGAMENT INJURY
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.33%
1/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Metabolism and nutrition disorders
FOOD INTOLERANCE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
2.0%
6/303 • Number of events 6 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DISORDER
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
PLANTAR FASCIITIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
SCOLIOSIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN BREAST NEOPLASM
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Nervous system disorders
BENIGN INTRACRANIAL HYPERTENSION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Nervous system disorders
HEADACHE
|
0.33%
1/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Psychiatric disorders
ANXIETY
|
0.33%
1/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Reproductive system and breast disorders
ENDOMETRIAL HYPERPLASIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Surgical and medical procedures
COLOSTOMY
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Surgical and medical procedures
MEDICAL DEVICE CHANGE
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.99%
3/303 • Number of events 3 • Date of Surgery Through 5 Years Post Implantation
|
|
Vascular disorders
THROMBOSIS
|
0.66%
2/303 • Number of events 2 • Date of Surgery Through 5 Years Post Implantation
|
|
Vascular disorders
HYPOTENSION
|
0.33%
1/303 • Number of events 1 • Date of Surgery Through 5 Years Post Implantation
|
Other adverse events
| Measure |
REALIZE™ Adjustable Gastric Band
n=303 participants at risk
All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.6%
17/303 • Number of events 18 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
VOMITING
|
62.0%
188/303 • Number of events 547 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
NAUSEA
|
37.3%
113/303 • Number of events 181 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
28.7%
87/303 • Number of events 140 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
CONSTIPATION
|
28.1%
85/303 • Number of events 106 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
DYSPEPSIA
|
25.7%
78/303 • Number of events 126 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
DYSPHAGIA
|
22.4%
68/303 • Number of events 91 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
17.2%
52/303 • Number of events 57 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
15.5%
47/303 • Number of events 59 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
OESOPHAGEAL DILATATION
|
13.9%
42/303 • Number of events 49 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
11.9%
36/303 • Number of events 40 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
FLATULENCE
|
11.6%
35/303 • Number of events 38 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
DIARRHOEA
|
9.2%
28/303 • Number of events 39 • Date of Surgery Through 5 Years Post Implantation
|
|
Gastrointestinal disorders
GASTRIC DILATATION
|
8.6%
26/303 • Number of events 28 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
FATIGUE
|
10.9%
33/303 • Number of events 41 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
IMPLANT SITE PAIN
|
10.9%
33/303 • Number of events 33 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
PYREXIA
|
7.6%
23/303 • Number of events 33 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
OEDEMA PERIPHERAL
|
5.9%
18/303 • Number of events 21 • Date of Surgery Through 5 Years Post Implantation
|
|
General disorders
CHEST PAIN
|
5.6%
17/303 • Number of events 19 • Date of Surgery Through 5 Years Post Implantation
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.6%
17/303 • Number of events 18 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
NASOPHARYNGITIS
|
20.8%
63/303 • Number of events 103 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
SINUSITIS
|
15.8%
48/303 • Number of events 75 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
13.9%
42/303 • Number of events 52 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
URINARY TRACT INFECTION
|
13.9%
42/303 • Number of events 59 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
INFLUENZA
|
11.6%
35/303 • Number of events 42 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
10.2%
31/303 • Number of events 38 • Date of Surgery Through 5 Years Post Implantation
|
|
Infections and infestations
BRONCHITIS
|
8.3%
25/303 • Number of events 30 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
58.1%
176/303 • Number of events 227 • Date of Surgery Through 5 Years Post Implantation
|
|
Injury, poisoning and procedural complications
PROCEDURAL NAUSEA
|
15.8%
48/303 • Number of events 49 • Date of Surgery Through 5 Years Post Implantation
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
8.3%
25/303 • Number of events 27 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
12.2%
37/303 • Number of events 45 • Date of Surgery Through 5 Years Post Implantation
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.6%
35/303 • Number of events 42 • Date of Surgery Through 5 Years Post Implantation
|
|
Nervous system disorders
HEADACHE
|
14.2%
43/303 • Number of events 48 • Date of Surgery Through 5 Years Post Implantation
|
|
Psychiatric disorders
DEPRESSION
|
12.2%
37/303 • Number of events 41 • Date of Surgery Through 5 Years Post Implantation
|
|
Psychiatric disorders
INSOMNIA
|
11.2%
34/303 • Number of events 41 • Date of Surgery Through 5 Years Post Implantation
|
|
Psychiatric disorders
ANXIETY
|
9.2%
28/303 • Number of events 33 • Date of Surgery Through 5 Years Post Implantation
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.3%
16/303 • Number of events 16 • Date of Surgery Through 5 Years Post Implantation
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
13.9%
42/303 • Number of events 46 • Date of Surgery Through 5 Years Post Implantation
|
|
Vascular disorders
HYPERTENSION
|
17.5%
53/303 • Number of events 62 • Date of Surgery Through 5 Years Post Implantation
|
Additional Information
Michael Schwiers, Principal Biostatistician
Ethicon Endo-Surgery
Phone: 513-337-1172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed that the first publication of results should be made in conjunction with the presentation of a joint, multicenter publication of the results with the PIs from all sites contributing data, analyses, and comments. If this publication was not submitted within 12 months after conclusion of the Study at all sites, or after Sponsor confirmed there would be no multicenter Study publication, whichever is first, the PIs could have published the results from their individual sites.
- Publication restrictions are in place
Restriction type: OTHER