Obesity
Conditions
Interventions
Patients will be treated with the ACE stapler to form stomach plications to
restrict the stomach and to create a feeling of satiety. This endoscopic
intervention will be performed during 1-2 hours.
Sponsors
Boston Scientific Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is willing and able to sign the Informed Consent Form (ICF). 2. Subject was previously enrolled in the *Open, prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACETM Stapler for the treatment of obesity (11-03)*.
Exclusion criteria
Exclusion criteria: 1. Subject is not willing and able to sign the ICF. 2. Subject was not previously enrolled in the *Open, prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACE Stapler for the treatment of obesity (11-03)*. 3. Subject is taking prescription or over-the-counter weight loss medications during the follow-up period. 4. Subject is taking anticoagulants or other medications which impede coagulation or platelet aggregation. 5. Subject is undergoing steroid or immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: adverse events, serious adverse events, unexpected adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness: weight loss, change in BMI, change in waist circumference, improvement of co morbidities, improvement in quality of life, diet, excercise and satiety. | — |
Countries
Netherlands
Outcome results
None listed