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The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during laparoscopic bariatric surgery. The goal of the study will be achieved by assessing the device performance and by reporting of peri- and postoperative complications in a prospectively maintained database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese patients eligible for laparoscopic bariatric surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Device | Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. | Conversion rate, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | At index procedure |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | At discharge, up to 1 week |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | Follow-up 1: 3 weeks after the procedure |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | Follow-up 2: 8 weeks after the procedure |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | Follow-up 3: 6 months after the procedure |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Device performance | Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy. | At index procedure |
| Device performance |
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Inclusion Criteria:
Exclusion Criteria:
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Obese patients eligible for laparoscopic bariatric surgery. This registry will collect data from 200 laparoscopic bariatric procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).
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| Name | Affiliation | Role |
|---|---|---|
| Bart Smet, Dr. | AZ Delta vzw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Delta vzw | Roeselare | Belgium |
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|
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. |
| Follow-up 4: 12 months after the procedure |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | Follow-up 5: 18 months after the procedure |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | Follow-up 6: 24 months after the procedure |
Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).
| At index procedure |
| Clinical efficacy | Weight loss | Follow-up 1: 3 weeks after the procedure |
| Clinical efficacy | Weight loss | Follow-up 2: 8 weeks after the procedure |
| Clinical efficacy | Weight loss | Follow-up 3: 6 months after the procedure |
| Clinical efficacy | Weight loss | Follow-up 4: 12 months after the procedure |
| Clinical efficacy | Weight loss | Follow-up 5: 18 months after the procedure |
| Clinical efficacy | Weight loss | Follow-up 6: 24 months after the procedure |
| Clinical efficacy | Comorbidity | Follow-up 4: 12 months after the procedure |
| Clinical efficacy | Comorbidity | Follow-up 6: 24 months after the procedure |
| 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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