This study will be performed to evaluate the safety of the ACE stapler for the treatment of obesity. The secondary objective is to evaluate effectiveness of the ACE stapler for the treatment of obesity.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: adverse events, serious adverse events, unexpected adverse events.
Secondary outcome
Effectiveness: weight loss, change in BMI, change in waist circumference,
improvement of co morbidities, improvement in quality of life, diet, excercise
and satiety.
Background summary
Obesity is a worldwide growing problem. Worldwide more than 300 million people
are obese. The number of persons with obesity in the USA has doubled in 30
years. Many of these persons are not helped by diets, behavioural changes or
exercise. Surgical procedures that are performed are gastric bypass,
laparoscopisch gastric banding and bypass procedures. With this facts in mind,
the idea of creating a minimally invasive device to treat patients with
obesity. Our previous experience with the Trans-oral endoscopic restrictive
device (TERIS) shows safety of the system. However. patency of the system was
no longer optimal months after the procedure. The system restrictor was
detached in several patients. The system plications were patent throughout the
study. For this new study plications will be created in the stomach plications.
Study objective
This study will be performed to evaluate the safety of the ACE stapler for the
treatment of obesity. The secondary objective is to evaluate effectiveness of
the ACE stapler for the treatment of obesity.
Study design
Prospective, single arm study
Intervention
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.
Study burden and risks
Patient burden includes several visits to the outpatient clinic with several a
blood tests. Following placement of the anchors a diet has to be followed.
During placement of the medical device, risks consist of risks associated with
anesthesia, a bleeding, a perforation or infection. Following the procedure a
soluble contrast X-ray will be performed to exclude stomach perforations
following the procedure. The stomach plications are created using transmural
staplers. These may detach after time. These staples will not harm any
gastrointestinal tract tissues and leave the body via the faeces.
One Boston Scientific Place 1
Natick MA 01760
US
One Boston Scientific Place 1
Natick MA 01760
US
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39418.018.12 |