Continuation of Follow-up for Patients who were Previously Enrolled in the Clinical Study: *Open, Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACE Stapler for the Treatment of Obesity.*
- Conditions
- Obesity1000301810017998
- Registration Number
- NL-OMON39582
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
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)*.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: adverse events, serious adverse events, unexpected adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Effectiveness: weight loss, change in BMI, change in waist circumference,<br /><br>improvement of co morbidities, improvement in quality of life, diet, excercise<br /><br>and satiety. </p><br>