Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of "real life" routine clinical practice
This is a single arm prospective, multi-center international, open-label, non-interventional, , post-market study. This registry is designed to further assess on a larger scale safety and efficacy of the endomina® and TAPES devices. Patients in need of endoscopic gastroplasty will be enrolled and followed-up for 36 months following hospital routine practice.
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome | Occurrence of Serious Adverse Device Effects at 12 months. | 12 months |
| Technical success | Technical success defined by the completion of the intended procedure without premature abortion due to technical reasons/device deficiency | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients, who require endoscopic gastroplasty (ESG) and who are selected by multidisciplinary team/investigators to be treated with the endomina® device.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mrs Leclercq | Contact | 003271495517 | pretti@endotools.be | |
| Mr Chau | Contact | 003271919409 | info@endotools.be |
| Name | Affiliation | Role |
|---|---|---|
| Mrs Leclercq | Endo Tools Therapeutics S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Tools Therapeutics S.A. | Recruiting | Gosselies | Wallonia | 6041 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |