A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery

Conditions
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Obesity, Roux-en-Y Gastric Bypass, Gastrectomy, Mini Gastric Bypass

Intervention / Treatment
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* Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥ 18 years of age at registry entry. Patient and investigator signed and dated the informed consent form prior to the index-procedure. Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities. Patient has a BMI ≥ 40 kg/m2. Patient is eligible for laparoscopic bariatric surgery. Exclusion Criteria: Patient is unable / unwilling to provide informed consent. Patient has a history of bariatric surgery. Patient is unable to comply with the registry protocol or proposed follow-up visits. Patient has a contra-indication for laparoscopic bariatric surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients eligible for laparoscopic bariatric surgery<br> | Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)<br>* Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |