Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
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 used in laparoscopic RYGB surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.

Official Title
-----------------
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery: a Monocentric Post-market Observational Study

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at study entry is at least 18 years. Patient must sign and date the informed consent form prior to the index-procedure. If the patient is not able to give informed consent, a legally authorized representative must give informed consent on his/her behalf. Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities. Patient has a BMI ≥ 40 kg/m2. Exclusion Criteria: Patient is pregnant. History of bariatric surgery. Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| To evaluate the efficacy of the laparoscopic RYGB surgery | Change of patient's weight | at 6 weeks follow-up | 
| To evaluate the efficacy of the laparoscopic RYGB surgery | Change of patient's weight | at 6 months follow-up | 
| To evaluate the efficacy of the laparoscopic RYGB surgery | Change of patient's weight | at 12 months follow-up | 
| To evaluate the efficacy of the laparoscopic RYGB surgery | Change of patient's weight | at 24 months follow-up |