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The OverStitch ™ Sx System (Apollo Endosurgery Inc., Austin, Tx, Usa) is a new generation of endoscopic suturing device. It is inserted into an endoscope allowing the approximation of Luc Karsentys soft tissue by placement of sutures. It is as effective a suture system as a surgical system. The OverStitch ™ Sx allows suturing in the upper and lower GI with a flexible single channel endoscope. Previously, the ™ Overstich was only compatible with an Olympus dual channel endoscope.
Thus, a wide range of interventions are possible, including gastric endoplastic sleeve (ESG), RYGB revision, anastomotic fistula repair and / or sleeve revision. In each of these indications, the OverStitch (OverStitch) ™ system has shown its effectiveness and safety.
The OverStitch Endoscopic ™ Suture System allows the entire digestive wall to be sutured through a flexible endoscope. Thus, a wide range of interventions are possible, including gastric pocket repair after gastric bypass surgery, anastomotic fistula repair, endoscopic treatment of digestive perforation, and endoscopic sleeve surgery. In each of these indications, the OverStitch system has demonstrated its effectiveness and safety. But this technique is recent, especially in France. In addition, no data has yet been released regarding the new Overstitch ™ Sx device compatible with all single channel endoscopes.
An observational study including patients in French centers that are experts in therapeutic endoscopy seems essential to us to better assess this new device and this new technique in practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OBESE PATIENT | Experimental | OverStitch™ Sx with a Single channel endoscop CO2 Insufflation, patient on decubitus dorsal, with intubate 3 to 7 sutures, from the antral ogiv to the cardia are done |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the sleeve gastroplasty with the endoscopic system Overstich SX | Procedure | the sleeve gastroplasty with the endoscopic system Overstich SX |
|
| Measure | Description | Time Frame |
|---|---|---|
| For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost | 6 MONTHS | |
| For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost | 12 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety Immediate morbidity | DAY 1 | |
| For sleeve revision, by the rate of patients with a percentage of total weight lost | 6 MONTHS | |
| For sleeve revision, by the rate of patients with a percentage of total weight lost |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Du Trocadero | Paris | 75016 | France |
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| 12 MONTHS |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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