Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
Number of participants with peri-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. |
at index-procedure |
|
Primary |
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. |
at discharge, up to 1 week |
|
Primary |
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. |
at 6 weeks follow-up |
|
Primary |
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. |
at 6 months follow-up |
|
Primary |
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
Number of participants with postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding. |
at 12 months follow-up |
|
Primary |
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. |
at 24 months follow-up |
|
Secondary |
To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
Number of procedures with technical success, defined as laparoscopic Roux-en-Y gastric bypass formation as intended without technical difficulties and without conversion to open laparotomy. |
at index-procedure |
|
Secondary |
To evaluate the performance of the easyEndoTM Universal Linear Cutting |
Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.). |
at index-procedure |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with peri-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. |
at index-procedure |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. |
at discharge, up to 1 week |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. |
at 6 weeks follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. |
at 6 months follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. |
at 12 months follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. |
at 24 months follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. |
at discharge, up to 1 week |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. |
at 6 weeks follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. |
at 6 months follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. |
at 12 months follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. |
at 24 months follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Change of patient's weight |
at 6 weeks follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Change of patient's weight |
at 6 months follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Change of patient's weight |
at 12 months follow-up |
|
Secondary |
To evaluate the efficacy of the laparoscopic RYGB surgery |
Change of patient's weight |
at 24 months follow-up |
|