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Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BariTon™ System implantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic gastric restriction and biliodigestive diversion | Device | The BariTon™ is endoscopically implanted and retrieved once treatment is completed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the BariTon™ | Number of patients with device implantation procedure success | 3 months |
| Safety of the BariTon™ | Incidence of device related adverse events | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the BariTon™ | Number of patients with device retrieval procedure success | 1 year |
| Safety of the BariTon™ | Incidence of device related adverse events |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe Naz | Contact | 0180206755 | 33 | christophe.naz@bariatek-medical.com |
| Youssef Biadillah | Contact | 0180206755 | 33 | youssef.biadillah@bariatek-medical.com |
| Name | Affiliation | Role |
|---|---|---|
| Adrian Sartoretto, Dr | The BMI Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BMI Clinic Double Bay | Recruiting | Sydney | New South Wales | 2028 | Australia |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 1 year |
| Efficacy of the BariTon™ | Assessment of clinical variables and other metrics (exploratory) | 1 year |
| Efficacy of the BariTon™ | Changes and number of diabetes medication taken | 1 year |
| Efficacy of the BariTon™ | Changes and number of statins medication taken | 1 year |
| Efficacy of the BariTon™ | Changes and number of blood pressure lowering medication taken | 1 year |
| Efficacy of the BariTon™ | Score changes in Weight related Quality of Life using IWQOL-Lite Questionnaire | 1 year |
| Efficacy of the BariTon™ | Score changes in food craving using CoEQ Questionnaire | 1 year |
| BMI Clinic Liverpool | Recruiting | Sydney | New South Wales | 2170 | Australia |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |