Morbid Obesity
Conditions
Brief summary
The purpose of this study is to collect additional safety, performance and effectiveness data of the Easyband gastric band medical device in the treatment of morbid obesity in 4 European countries where the device is a CE marked approved product.
Interventions
DEVICEEasyband®
The Easyband adjustable gastric band device is implanted laparoscopically around the top of the stomach to create a small pouch. Adjustments to increase or decrease the stoma size are made non-invasively by telemetric connection between an internal and external antenna.
Sponsors
Allergan Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Demonstrated failure in losing weight with non-invasive therapies * BMI ≥ 40 kg/m2, or BMI ≥ 35 kg/m2 and \< 40 kg/m2 with one or more significant medical conditions related to obesity
Exclusion criteria
* patients with BMI greater than 60 kg/m2 * patients who are not indicated for laparoscopic bariatric surgery * patients with known allergies to implant materials such as silicone and PEEK * patients whose abdominal structures have been damaged during preceding surgical procedures * pregnant women * patients under the age of 18 years * patients treated with steroids * patients addicted to alcohol or drugs, or who are mentally unstable, or who may not comply with the follow-up and dietary restrictions * patients already implanted with a device sensitive to radio-frequency emissions such as implanted pacemaker, defibrillators, cochlear implants, implantable pumps etc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Ease of Implantation | < 1day | Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is very easy and 5 is impossible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Excess Weight Loss | 12 months | Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight. |
| Change in BMI | 12 months | Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months |
| Change in Weight | 12 months | Change in weight (in kilograms) at baseline to 12 months |
Countries
Belgium, Italy, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Easyband | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Easyband |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants |
| Age, Continuous | 39.0 years STANDARD_DEVIATION 11.23 |
| Region of Enrollment Belgium | 33 participants |
| Region of Enrollment Italy | 21 participants |
| Region of Enrollment Netherlands | 29 participants |
| Region of Enrollment United Kingdom | 27 participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 87 / 110 |
| serious Total, serious adverse events | 29 / 110 |
Outcome results
Primary
Feasibility and Ease of Implantation
Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is very easy and 5 is impossible.
Time frame: < 1day
Population: Intent-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Easyband | Feasibility and Ease of Implantation | Introduction of Easyband into the abdomen | 71.8 percentage of subjects |
| Easyband | Feasibility and Ease of Implantation | Placing Easyband around the stomach | 81.8 percentage of subjects |
| Easyband | Feasibility and Ease of Implantation | Clipping of the Easyband around the stomach | 88.2 percentage of subjects |
Secondary
Change in BMI
Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Easyband | Change in BMI | -7.23 kg/m2 |
Secondary
Change in Weight
Change in weight (in kilograms) at baseline to 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Easyband | Change in Weight | -20.70 pounds |
Secondary
% Excess Weight Loss
Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Easyband | % Excess Weight Loss | 30.73 percentage of excess weight loss |