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.
Study Type
OBSERVATIONAL
Enrollment
200
Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.
AZ Delta vzw
Roeselare, Belgium
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow-up 6: 24 months after the procedure
Device performance
Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy.
Time frame: At index procedure
Device performance
Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).
Time frame: At index procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 1: 3 weeks after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 2: 8 weeks after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 3: 6 months after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 4: 12 months after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 5: 18 months after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 6: 24 months after the procedure
Clinical efficacy
Comorbidity
Time frame: Follow-up 4: 12 months after the procedure
Clinical efficacy
Comorbidity
Time frame: Follow-up 6: 24 months after the procedure
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